<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03017235</url>
  </required_header>
  <id_info>
    <org_study_id>000253</org_study_id>
    <nct_id>NCT03017235</nct_id>
  </id_info>
  <brief_title>A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPIK® for Colon Cleansing in Preparation for Colonoscopy</brief_title>
  <official_title>A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution Versus Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Powder for Oral Solution (PREPOPIK®) for Colon Cleansing in Preparation for Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ferring Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ferring Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous&#xD;
      Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing&#xD;
      colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Actual">October 12, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Subjects Classified as a Responder Defined by &quot;Excellent&quot; or &quot;Good&quot;</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (&gt;90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (&gt;90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (&gt;90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (&lt;90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is &quot;excellent&quot; or &quot;good&quot; on this 4-point scale.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)</measure>
    <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
    <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Treatment-emergent Adverse Events(AEs)</measure>
    <time_frame>From baseline (screening) up to day 28 after colonoscopy</time_frame>
    <description>Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Changes in Vital Signs</measure>
    <time_frame>From baseline (screening) up to day 28 after colonoscopy</time_frame>
    <description>Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Changes in Electrocardiogram (ECG)</measure>
    <time_frame>At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy</time_frame>
    <description>Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Changes in Laboratory Values</measure>
    <time_frame>At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy</time_frame>
    <description>Rated by the investigator based on out of range laboratory values</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">917</enrollment>
  <condition>Bowel Preparation</condition>
  <arm_group>
    <arm_group_label>NaP/MC Oral Solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PREPOPIK®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution</intervention_name>
    <description>Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.</description>
    <arm_group_label>NaP/MC Oral Solution</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder</intervention_name>
    <description>Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
    <arm_group_label>PREPOPIK®</arm_group_label>
    <other_name>PREPOPIK®</other_name>
    <other_name>PicoPrep®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or non-pregnant female subjects aged 18 to 80 years, inclusive, being scheduled&#xD;
             to undergo elective colonoscopy&#xD;
&#xD;
          -  Females of childbearing potential must agree to use an adequate contraception during&#xD;
             the course of the trial. Accepted forms of contraception are: i.e., implants,&#xD;
             injectables, hormonal intrauterine device, combined hormonal contraceptives, sexual&#xD;
             abstinence, and vasectomized sexual partner. Premenopausal women who are of&#xD;
             childbearing potential must have a negative serum pregnancy test result at screening&#xD;
             and a negative urine pregnancy test result at randomization prior to colonoscopy. In&#xD;
             the case of oral contraceptive use, women should have been taking the same pill&#xD;
             consistently for a minimum of twelve (12) weeks before taking study medication.&#xD;
             Sterilized or postmenopausal women may also participate. Women are considered to be&#xD;
             postmenopausal and are not considered to be of childbearing potential if they have had&#xD;
             twelve (12) months of natural (spontaneous) amenorrhea with an appropriate clinical&#xD;
             profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical&#xD;
             bilateral oophorectomy (with or without hysterectomy) or tubal ligation.&#xD;
&#xD;
          -  An average of at least 3 spontaneous bowel movements per week for one month prior to&#xD;
             the colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected gastrointestinal obstruction, perforation, ileus, or gastric&#xD;
             retention&#xD;
&#xD;
          -  Acute intestinal or gastric ulceration&#xD;
&#xD;
          -  Severe acute inflammatory bowel disease (IBD), toxic colitis, or toxic megacolon&#xD;
&#xD;
          -  Undergoing colonoscopy for foreign body removal or decompression&#xD;
&#xD;
          -  Reduced level of consciousness or inability to swallow without aspiration&#xD;
&#xD;
          -  Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior&#xD;
             endoscopic procedures&#xD;
&#xD;
          -  Upper gastrointestinal surgery (gastrectomy, gastric banding, gastric by-pass)&#xD;
&#xD;
          -  Uncontrolled angina and/or myocardial infarction (MI) within last three months,&#xD;
             congestive heart failure (CHF), uncontrolled hypertension, or ascites&#xD;
&#xD;
          -  Severely reduced renal function (&lt;30 mL/min/1.73 m2)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Any clinically relevant abnormal findings in medical history, physical examination,&#xD;
             vital signs, ECG, clinical chemistry, hematology, coagulation, or urinalysis at&#xD;
             Screening Visit 1&#xD;
&#xD;
          -  Rhabdomyolysis&#xD;
&#xD;
          -  Chronic nausea and vomiting&#xD;
&#xD;
          -  Hypermagnesemia&#xD;
&#xD;
          -  Undergoing treatment with Lithium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development Support</last_name>
    <role>Study Director</role>
    <affiliation>Ferring Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Associated Gastroenterology Medical Group</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GW Research, Inc.</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Precision Research Institute</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Connecticut Clinical Research Foundation</name>
      <address>
        <city>Bristol</city>
        <state>Connecticut</state>
        <zip>06010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Clinical Research Group</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nature Coast Clinical Research</name>
      <address>
        <city>Inverness</city>
        <state>Florida</state>
        <zip>34452</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Gastrointestinal Research Group LLC</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11023</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinston Medical Specialists, PA</name>
      <address>
        <city>Kinston</city>
        <state>North Carolina</state>
        <zip>28501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Research Associates, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hillmont GI</name>
      <address>
        <city>Flourtown</city>
        <state>Pennsylvania</state>
        <zip>19031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Research Institute</name>
      <address>
        <city>Ogden</city>
        <state>Utah</state>
        <zip>84405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hotel Dieu Hospital</name>
      <address>
        <city>Kingston</city>
        <zip>K7L 5G2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canadian Phase Onward, Inc.</name>
      <address>
        <city>Toronto</city>
        <zip>M3J 2C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <results_first_submitted>September 3, 2018</results_first_submitted>
  <results_first_submitted_qc>October 18, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 14, 2018</results_first_posted>
  <last_update_submitted>October 18, 2018</last_update_submitted>
  <last_update_submitted_qc>October 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Picosulfate sodium</mesh_term>
    <mesh_term>Magnesium Oxide</mesh_term>
    <mesh_term>Sodium Citrate</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 25, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03017235/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT03017235/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>NaP/MC Oral Solution</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.&#xD;
Split dose regimen: Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.</description>
        </group>
        <group group_id="P2">
          <title>PREPOPIK®</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject.&#xD;
Split dose regimen :Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.&#xD;
Subjects began treatment (first dose) the evening before colonoscopy between 5:00 PM and 9:00 PM, and completed treatment (second dose) the following day, at least 5 hours, but no more than 9 hours, prior to the colonoscopy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="456"/>
                <participants group_id="P2" count="461"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="444"/>
                <participants group_id="P2" count="447"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Cancer, emergency, allergy, active UTI</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Modified intention-to-treat (mITT) was considered as the main analysis set. mITT was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
      <group_list>
        <group group_id="B1">
          <title>NaP/MC Oral Solution</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution: Supplied as ready-to-drink without further reconstitution before administration</description>
        </group>
        <group group_id="B2">
          <title>PREPOPIK®</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="448"/>
            <count group_id="B2" value="453"/>
            <count group_id="B3" value="901"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.2" spread="11.04"/>
                    <measurement group_id="B2" value="57.1" spread="10.85"/>
                    <measurement group_id="B3" value="57.2" spread="10.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="250"/>
                    <measurement group_id="B3" value="502"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="196"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="399"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="139"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="380"/>
                    <measurement group_id="B2" value="381"/>
                    <measurement group_id="B3" value="761"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="90"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="376"/>
                    <measurement group_id="B2" value="394"/>
                    <measurement group_id="B3" value="770"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child-bearing potential</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Child bearing potential</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="250"/>
                    <measurement group_id="B3" value="502"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="203"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="406"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Classified as a Responder Defined by &quot;Excellent&quot; or &quot;Good&quot;</title>
        <description>The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (&gt;90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (&gt;90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (&gt;90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (&lt;90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is &quot;excellent&quot; or &quot;good&quot; on this 4-point scale.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Classified as a Responder Defined by &quot;Excellent&quot; or &quot;Good&quot;</title>
          <description>The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (&gt;90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (&gt;90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (&gt;90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (&lt;90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is &quot;excellent&quot; or &quot;good&quot; on this 4-point scale.</description>
          <population>The primary efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.7" lower_limit="84.3" upper_limit="90.6"/>
                    <measurement group_id="O2" value="81.5" lower_limit="77.6" upper_limit="84.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>The NI margin for the difference between treatments (NaP/MC Oral Solution minus PREPOPIK) was pre-specified at -8% (absolute). If NI was demonstrated for both the primary efficacy endpoint and the secondary efficacy endpoint for the right colon, and if the lower bound of the CI was above 0%, then superiority was declared for the primary endpoint. Thus, the pre-specified superiority analysis was conducted at a one-sided significance level of 2.5%.</non_inferiority_desc>
            <p_value>0.0067</p_value>
            <p_value_desc>The above p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.</p_value_desc>
            <method>Weighted Percentage Difference</method>
            <method_desc>CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>6.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>10.9</ci_upper_limit>
            <other_analysis_desc>Lower limit of 95% CI &gt; 0% for the primary efficacy endpoint combined with outcome of secondary efficacy endpoint for the right colon allowed for superiority analysis.</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon</title>
        <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon</title>
          <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.2" lower_limit="91.6" upper_limit="96.2"/>
                    <measurement group_id="O2" value="89.6" lower_limit="86.4" upper_limit="92.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in the percentage of subjects on NaP/MC or PREPOPIK (NaP/MC - PREPOPIK)</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.</non_inferiority_desc>
            <p_value>0.0099</p_value>
            <p_value_desc>The p-value was calculated for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran-Mantel-Haenszel-weight.</p_value_desc>
            <method>Weighted Percentage Difference</method>
            <method_desc>CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>4.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>8.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon</title>
        <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon</title>
          <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.0" lower_limit="93.7" upper_limit="97.6"/>
                    <measurement group_id="O2" value="94.0" lower_limit="91.4" upper_limit="96.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC - PREPOPIK)</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to right colon cleansing in preparation for colonoscopy.</non_inferiority_desc>
            <p_value>0.1781</p_value>
            <p_value_desc>The above p-value was tested for superiority and was based on the stratified percentage difference test, where the stratification weight is based on Cochran Mantel Haenszel weight.</p_value_desc>
            <method>Weighted Percentage Difference</method>
            <method_desc>CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>1.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>4.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon</title>
        <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon</title>
          <description>The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.&#xD;
The BBPS scale:&#xD;
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.6" lower_limit="92.1" upper_limit="96.5"/>
                    <measurement group_id="O2" value="91.2" lower_limit="88.2" upper_limit="93.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in percentage of subjects on NaP/MC Oral Solution or PREPOPIK® (NaP/MC-PREPOPIK®)</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>If the lower limit of the 95% CI was greater than the margin (-8%), the null hypothesis was rejected and NaP/MC Oral Solution was claimed as non-inferior to PREPOPIK with respect to colon cleansing in preparation for colonoscopy.</non_inferiority_desc>
            <p_value>0.0391</p_value>
            <p_value_desc>The above p-value was for superiority and was based on the stratified percentage difference, where the stratification weight is based on Cochran-Mantel-Haenszel weight.</p_value_desc>
            <method>Weighted Percentage Difference</method>
            <method_desc>CIs (treatment difference) were calculated using stratified (by site) percentage difference where, weights= Cochran-Mantel-Haenszel weights for site</method_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>3.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.2</ci_lower_limit>
            <ci_upper_limit>6.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>≤3/week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 to 8/week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="264"/>
                    <measurement group_id="O2" value="299"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥9/week</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Response not provided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="443"/>
                    <measurement group_id="O2" value="448"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25% - 50%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50% - 75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥75%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Response not provided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Easy to acceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400"/>
                    <measurement group_id="O2" value="433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Very difficult</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unacceptable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not willing at all</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Somewhat willing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mostly willing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="361"/>
                    <measurement group_id="O2" value="408"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No difficulties</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                    <measurement group_id="O2" value="320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No health issues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Response not provided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="371"/>
                    <measurement group_id="O2" value="426"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="382"/>
                    <measurement group_id="O2" value="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335"/>
                    <measurement group_id="O2" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="416"/>
                    <measurement group_id="O2" value="435"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="403"/>
                    <measurement group_id="O2" value="402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="427"/>
                    <measurement group_id="O2" value="432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Not bothered-Mildly bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="396"/>
                    <measurement group_id="O2" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderately bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severely bothered</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="261"/>
                    <measurement group_id="O2" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Response not provided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not applicable</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>GoLytely</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moviprep</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MiraLax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Do not remember</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="137"/>
                    <measurement group_id="O2" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)</title>
        <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
        <time_frame>During colonoscopy procedure (5-9 hours after completed treatment)</time_frame>
        <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)</title>
          <description>Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.</description>
          <population>The efficacy analysis was conducted for the mITT analysis set and was defined as all ITT subjects who received at least 1 dose of treatment. The mITT analysis set was analyzed according to randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Worse than before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>About the same as before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Better than before</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190"/>
                    <measurement group_id="O2" value="209"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Response not provided</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Treatment-emergent Adverse Events(AEs)</title>
        <description>Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.</description>
        <time_frame>From baseline (screening) up to day 28 after colonoscopy</time_frame>
        <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Treatment-emergent Adverse Events(AEs)</title>
          <description>Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.</description>
          <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
          <units>Percentage of adverse events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.4"/>
                    <measurement group_id="O2" value="84.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Changes in Vital Signs</title>
        <description>Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position</description>
        <time_frame>From baseline (screening) up to day 28 after colonoscopy</time_frame>
        <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Changes in Vital Signs</title>
          <description>Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position</description>
          <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Orthostatic hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood pressure increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypotension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Changes in Electrocardiogram (ECG)</title>
        <description>Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.</description>
        <time_frame>At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy</time_frame>
        <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Changes in Electrocardiogram (ECG)</title>
          <description>Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.</description>
          <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Bradycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bundle branch block left</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Extrasystoles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ventricular extrasystoles</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Atrial fibrillation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bundle branch block right</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Palpitations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sinus bradycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tachycardia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac murmur</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Changes in Laboratory Values</title>
        <description>Rated by the investigator based on out of range laboratory values</description>
        <time_frame>At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy</time_frame>
        <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>NaP/MC Oral Solution</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles, per subject without further reconstitution, before administration.</description>
          </group>
          <group group_id="O2">
            <title>PREPOPIK®</title>
            <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder: Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Changes in Laboratory Values</title>
          <description>Rated by the investigator based on out of range laboratory values</description>
          <population>The Safety analysis set comprised all subjects who received any amount of study medication. The Safety analysis set was analyzed according to the actual treatment received.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="448"/>
                <count group_id="O2" value="453"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology: Anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Leukopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Lymphocytosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematology: Normocytic anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemotology: Platelet count decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical Chemistry: Hypermagnesaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry:Blood bicarbonate decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hypokalemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hyperglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hypoglycaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hyperkalaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hypomagnasaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Blood creatinine increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Blood potassium decreased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hypochloraemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinical chemistry: Hyperbilirubinaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinalysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline (screening) upto 28 days after colonoscopy.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NaP/MC Oral Solution</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution&#xD;
Supplied as two 160 mL ready-to-drink bottles per subject without further reconstitution before administration.</description>
        </group>
        <group group_id="E2">
          <title>PREPOPIK®</title>
          <description>Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder&#xD;
Supplied as two packets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="448"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="448"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="448"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="448"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="448"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Rectal adenocarcinoma</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="448"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Carcinoid tumour of the gastrointestinal tract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="448"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="378" subjects_at_risk="448"/>
                <counts group_id="E2" subjects_affected="384" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="162" subjects_affected="150" subjects_at_risk="448"/>
                <counts group_id="E2" events="167" subjects_affected="155" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="157" subjects_affected="93" subjects_at_risk="448"/>
                <counts group_id="E2" events="181" subjects_affected="105" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="75" subjects_affected="70" subjects_at_risk="448"/>
                <counts group_id="E2" events="73" subjects_affected="70" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Diverticulum</sub_title>
                <counts group_id="E1" events="64" subjects_affected="64" subjects_at_risk="448"/>
                <counts group_id="E2" events="59" subjects_affected="59" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" events="26" subjects_affected="25" subjects_at_risk="448"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="453"/>
              </event>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="29" subjects_affected="27" subjects_at_risk="448"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="448"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" events="237" subjects_affected="133" subjects_at_risk="448"/>
                <counts group_id="E2" events="211" subjects_affected="128" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="27" subjects_affected="27" subjects_at_risk="448"/>
                <counts group_id="E2" events="34" subjects_affected="30" subjects_at_risk="453"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Global Clinical Compliance</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <phone>+1 833-548-1402</phone>
      <email>DKO-Disclosure@ferring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03017235
org study id: 000253
nct id: NCT03017235
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the Sodium Picosulfate, Magnesium Oxide and Anhydrous
      Citric Acid Oral Solution with PREPOPIK® for colon cleansing in adult subjects undergoing
      colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Percentage of Subjects Classified as a Responder Defined by "Excellent" or "Good"
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: The efficacy of overall colon cleansing in terms of responders was measured by a blinded endoscopist using the Modified Aronchick Scale. Modified Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed).The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Right Segment of the Colon
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the right segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Transverse Segment of the Colon
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the transverse segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
measure: Percentage of Subjects Classified as a Responder Defined by a Score ≥2 in the Left Segment of the Colon
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: The percentage of subjects classified as responders, defined by a Boston Bowel Preparation Scale (BBPS) score ≥2 in the left segment of the colon was determined.
The BBPS scale:
0= Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared; 1= Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool, and/or opaque liquid; 2= Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well; 3= Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Many Bowel Movements Did You Have in the Week Prior to Starting Colon Preparation?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Much Bowel Preparation Was Left in Bottle After Drinking it?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Was the Bowel Preparation Tolerable?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Willing Are You to Use This Preparation in the Future?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (If Difficulties Existed, Were They Due to Your Current Health Status?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure. Subjects in response to questions could provide multiple response if applicable.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bad Taste in Mouth?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Gastric Fullness?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Lack of Sleep From Excessive Bathroom Trips?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Nausea, Vomiting?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Bloating/Abdominal Distension/Gas?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Abdominal Pain/Cramps?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (How Bothered Were You During Bowel Prep by Headache?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Was This Your First Colonoscopy?)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Previous Bowel Preparation)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Frequency of Each Category on the Subject Tolerability Questionnaire (Tolerability Compared to Previous Bowel Prepreparations)
time frame: During colonoscopy procedure (5-9 hours after completed treatment)
description: Subject tolerability and satisfaction with the bowel cleansing preparation were assessed by the validated Mayo Clinic Bowel Prep Tolerability Questionnaire. This simple, comprehensive questionnaire, developed to evaluate the tolerability of various types of bowel preparations, was administered to the subject at Visit 3 prior to the colonoscopy procedure.
measure: Percentage of Treatment-emergent Adverse Events(AEs)
time frame: From baseline (screening) up to day 28 after colonoscopy
description: Collected as any AE that begins during the treatment period defined as the period during which a subject receives IMP. All endoscopy findings were reported as AEs while cancers/malignancies detected on endoscopy were reported as SAEs.
measure: Clinically Significant Changes in Vital Signs
time frame: From baseline (screening) up to day 28 after colonoscopy
description: Blood pressure and pulse will be measured after at least 5 minutes of rest in supine position and after 3 minutes in standing position
measure: Clinically Significant Changes in Electrocardiogram (ECG)
time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
description: Measured by standard 12-lead ECG. At each visit when an ECG was done, the investigator reviewed and initialed the tracing, which was then stored with the subject's source documents. The baseline ECG performed at the Screening Visit was reviewed for major abnormalities before dosing.
measure: Clinically Significant Changes in Laboratory Values
time frame: At baseline (screening), on the day of colonoscopy, 1-2 days after colonoscopy, 7 days after colonoscopy and 28 days after colonoscopy
description: Rated by the investigator based on out of range laboratory values
arm group label: NaP/MC Oral Solution
arm group type: Experimental
description: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid (NaP/MC) Oral Solution
arm group label: PREPOPIK®
arm group type: Active Comparator
intervention type: Drug
intervention name: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution
description: Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
arm group label: NaP/MC Oral Solution
intervention type: Drug
intervention name: Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder
description: Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
arm group label: PREPOPIK®
other name: PREPOPIK®
other name: PicoPrep®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Picosulfate sodium
mesh term: Magnesium Oxide
mesh term: Sodium Citrate
mesh term: Citric Acid
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 