<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/NCT02239692</url>
  </required_header>
  <id_info>
    <org_study_id>000121</org_study_id>
    <secondary_id>2014-001062-10</secondary_id>
    <nct_id>NCT02239692</nct_id>
  </id_info>
  <brief_title>A Trial Comparing the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule for Colon Cleansing in Preparation for Colonoscopy</brief_title>
  <acronym>OPTIMA</acronym>
  <official_title>A Randomised, Assessor-blinded, Multi-centre Trial Comparing the Efficacy, Safety and Tolerability of the PICOPREP Tailored Dosing Schedule to the PICOPREP Day-before Dosing Schedule 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy,&#xD;
      safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before&#xD;
      dosing schedule for colon cleansing in preparation for colonoscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ascending Colon Cleansing Responder Status (ITT)</measure>
    <time_frame>Day 1 (day of colonoscopy)</time_frame>
    <description>Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and Intensity of Adverse Events</measure>
    <time_frame>From baseline (screening) up to day 10 after colonoscopy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)</measure>
    <time_frame>From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)</time_frame>
    <description>Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)</measure>
    <time_frame>From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)</time_frame>
    <description>Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">204</enrollment>
  <condition>Bowel Cleansing</condition>
  <arm_group>
    <arm_group_label>PICOPREP day-before dosing schedule</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Both doses administered the day before colonoscopy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PICOPREP tailored dosing schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PICOPREP</intervention_name>
    <description>Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
    <arm_group_label>PICOPREP day-before dosing schedule</arm_group_label>
    <arm_group_label>PICOPREP tailored dosing schedule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, 18 years of age or above, being scheduled to undergo elective&#xD;
             colonoscopy&#xD;
&#xD;
          -  Subjects must have had more than or equal to 3 spontaneous bowel movements (i.e.&#xD;
             without use of any laxative within 24 hours before the bowel movement, with the&#xD;
             exception for bulk-forming laxatives (ATC code A06AC)) per week for one month prior to&#xD;
             the colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)&#xD;
&#xD;
          -  Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)&#xD;
&#xD;
          -  Any prior colorectal surgery, excluding appendectomy, haemorrhoid surgery or prior&#xD;
             endoscopic procedures&#xD;
&#xD;
          -  Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic&#xD;
             pseudoobstruction, hypomotility syndrome)&#xD;
&#xD;
          -  Ascites&#xD;
&#xD;
          -  Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis,&#xD;
             ileus)&#xD;
&#xD;
          -  Upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)&#xD;
&#xD;
          -  Severely reduced renal function (Glomerular filtration rate (GFR) &lt;30 (mL/min/1.73&#xD;
             m2))&#xD;
&#xD;
          -  The subject is a pregnant (positive urine pregnancy test at Visit 1 or Visit 2) woman.&#xD;
             Women of childbearing potential (defined, for the purpose of this trial, as all&#xD;
             females post-puberty, not postmenopausal ≥2 years, or not surgically sterile) who do&#xD;
             not agree to use one of the following methods of birth control from the day of signing&#xD;
             the Informed Consent Form until End of Trial Visit are excluded:&#xD;
&#xD;
               1. Transdermal patch&#xD;
&#xD;
               2. Hormonal contraception (i.e., oral, implant, or injectable contraceptive)&#xD;
&#xD;
               3. Double-barrier birth control (i.e., condom plus intrauterine device, diaphragm&#xD;
                  plus spermicide, etc.)&#xD;
&#xD;
               4. Maintenance of a monogamous relationship with a male who has been surgically&#xD;
                  sterilised by vasectomy&#xD;
&#xD;
               5. Sexual abstinence&#xD;
&#xD;
          -  The subject is a breast-feeding or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>Ed Herriot Hopital (there may be other sites in this country)</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gastroenterologie am Bayerischen Platz (there may be other sites in this country)</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Alkmaar (there may be other sites in this country)</name>
      <address>
        <city>Alkmaar</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 15, 2014</study_first_posted>
  <results_first_submitted>May 17, 2016</results_first_submitted>
  <results_first_submitted_qc>May 17, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 23, 2016</results_first_posted>
  <last_update_submitted>May 17, 2016</last_update_submitted>
  <last_update_submitted_qc>May 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2016</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>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited from 11 sites in Germany, France and the Netherlands from Nov 2014 to Jun 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PICOPREP Day-before Dosing Schedule</title>
          <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
        </group>
        <group group_id="P2">
          <title>PICOPREP Tailored Dosing Schedule</title>
          <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Intention-to-treat Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="73"/>
                <participants group_id="P2" count="131"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="70"/>
                <participants group_id="P2" count="125"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Incomplete colonoscopy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </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>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reason</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The intention-to-treat (ITT) analysis set consisted of all randomized subjects.</population>
      <group_list>
        <group group_id="B1">
          <title>PICOPREP Day-before Dosing Schedule</title>
          <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
        </group>
        <group group_id="B2">
          <title>PICOPREP Tailored Dosing Schedule</title>
          <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</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="73"/>
            <count group_id="B2" value="131"/>
            <count group_id="B3" value="204"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="85"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="56.6" spread="15.1"/>
                    <measurement group_id="B2" value="58.4" spread="13.3"/>
                    <measurement group_id="B3" value="57.8" spread="13.9"/>
                  </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="43"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="84"/>
                  </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="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="130"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale</title>
        <description>Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>The ITT analysis set consisted of all randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale</title>
          <description>Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
          <population>The ITT analysis set consisted of all randomized subjects.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="3.54"/>
                    <measurement group_id="O2" value="4.2" spread="3.75"/>
                  </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>Null hypothesis was no treatment difference between the two dosing schedules.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>p-value corresponds to a two-sided test of superiority.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.</method_desc>
            <param_type>Adjusted estimated mean difference</param_type>
            <param_value>-3.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.99</ci_lower_limit>
            <ci_upper_limit>-2.87</ci_upper_limit>
            <estimate_desc>Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale</title>
        <description>Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale</title>
          <description>Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).</description>
          <population>The per-protocol (PP) analysis set consisted of all the subjects included in ITT analysis set, but excluding subjects with major protocol deviations (18 subjects) that would impact efficacy analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="120"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" spread="3.38"/>
                    <measurement group_id="O2" value="3.7" spread="3.14"/>
                  </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>Null hypothesis was no treatment difference between the two dosing schedules.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority is assessed by examining whether the upper limit of the 95% confidence interval is less than the specified non-inferiority margin of 1.5 points.</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>p-value corresponds to a two-sided test of superiority.</p_value_desc>
            <method>ANCOVA</method>
            <method_desc>ANCOVA with treatment, country and time of colonoscopy (AM/PM) as factors.</method_desc>
            <param_type>Adjusted estimated mean difference</param_type>
            <param_value>-4.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.34</ci_lower_limit>
            <ci_upper_limit>-3.41</ci_upper_limit>
            <estimate_desc>Treatment difference in mean total Ottawa Scale score was calculated as PICOPREP tailored dosing schedule minus PICOPREP day-before dosing schedule.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ascending Colon Cleansing Responder Status (ITT)</title>
        <description>Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.</description>
        <time_frame>Day 1 (day of colonoscopy)</time_frame>
        <population>The ITT analysis set consisted of all randomized subjects.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Ascending Colon Cleansing Responder Status (ITT)</title>
          <description>Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.</description>
          <population>The ITT analysis set consisted of all randomized subjects.</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="73"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1"/>
                    <measurement group_id="O2" value="61.1"/>
                  </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>Null hypothesis was no treatment difference between the two dosing schedules.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>p-value corresponds to a two-sided test of superiority.</p_value_desc>
            <method>Regression, Logistic</method>
            <method_desc>Logistic regression with the failure/success status as dependent variable, and treatment, country and timing of colonoscopy as factors.</method_desc>
            <param_type>Adjusted estimated odds ratio</param_type>
            <param_value>9.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.36</ci_lower_limit>
            <ci_upper_limit>19.32</ci_upper_limit>
            <estimate_desc>The estimated odds ratio compares the odds of being a responder in the PICOPREP tailored dosing schedule vs. the PICOPREP day-before dosing schedule.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Frequency and Intensity of Adverse Events</title>
        <time_frame>From baseline (screening) up to day 10 after colonoscopy</time_frame>
        <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Frequency and Intensity of Adverse Events</title>
          <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frequency of all adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of mild adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Frequency of moderate adverse events</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>Frequency of severe adverse events</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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)</title>
        <description>Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).</description>
        <time_frame>From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)</time_frame>
        <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)</title>
          <description>Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).</description>
          <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinically significant change in pulse</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>
              <title>Clinically significant change in blood pressure</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>
        <type>Secondary</type>
        <title>Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)</title>
        <description>Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.</description>
        <time_frame>From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)</time_frame>
        <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
        <group_list>
          <group group_id="O1">
            <title>PICOPREP Day-before Dosing Schedule</title>
            <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
          <group group_id="O2">
            <title>PICOPREP Tailored Dosing Schedule</title>
            <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
          </group>
        </group_list>
        <measure>
          <title>Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)</title>
          <description>Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.</description>
          <population>The Safety analysis set consisted of all treated subjects and was analyzed according to the actual treatment received.</population>
          <units>subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="70"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Clinically significant change in haematology</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>
              <title>Clinically significant change in clinical chem</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>
              <title>Clinically significant change in coagulation</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>
              <title>Clinically significant change in 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>Adverse events were recorded from baseline till the end-of-trial (10 days after colonoscopy).</time_frame>
      <group_list>
        <group group_id="E1">
          <title>PICOPREP Day-before Dosing Schedule</title>
          <description>Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
        </group>
        <group group_id="E2">
          <title>PICOPREP Tailored Dosing Schedule</title>
          <description>Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.&#xD;
PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="4" subjects_at_risk="70"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Gilbert's syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Anorectal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Hypermagnesaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="70"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="125"/>
              </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>Clinical Development Support</name_or_title>
      <organization>Ferring Pharmaceuticals</organization>
      <email>DK0-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/NCT02239692
org study id: 000121
secondary id: 2014-001062-10
nct id: NCT02239692
lead sponsor: 
has dmc: No
This was a phase 3, randomised, assessor-blinded, multi-centre trial comparing the efficacy,
      safety and tolerability of a PICOPREP tailored dosing schedule to the PICOPREP day-before
      dosing schedule for colon cleansing in preparation for colonoscopy.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Overall Colon Cleansing Procedure (ITT) Measured by the Total Ottawa Scale
time frame: Day 1 (day of colonoscopy)
description: Measured by the total Ottawa Scale score during the colonoscopy performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
measure: Overall Colon Cleansing Procedure (PP) Measured by the Total Ottawa Scale
time frame: Day 1 (day of colonoscopy)
description: Measured by the total Ottawa Scale score during the colonoscopy which is performed by a colonoscopist blinded to the dosing schedules. Total Ottawa Scale score was computed by adding the ratings (0 to 4; 0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate) for each of the three colon segments and the overall fluid quality rating (0 to 2). The final score ranged from 0 (excellent) to 14 (solid stool in each colon segment and lots of fluid).
measure: Ascending Colon Cleansing Responder Status (ITT)
time frame: Day 1 (day of colonoscopy)
description: Percentage of subjects classified as responders, i.e. Ottawa Scale score of either 0 (excellent) or 1 (good), during colonoscopy performed by a colonoscopist blinded to the dosing schedules.
measure: Frequency and Intensity of Adverse Events
time frame: From baseline (screening) up to day 10 after colonoscopy
measure: Clinically Significant Changes in Vital Signs (Pulse and Blood Pressure)
time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
description: Mean change from baseline to the end-of-trial was observed for pulse and blood pressure (systolic and diastolic).
measure: Clinically Significant Changes in Laboratory Values (Haematology, Clinical Chemistry, Coagulation and Urinalysis)
time frame: From baseline (screening) up to day 10 after colonoscopy (inclusive of assessment at each visit)
description: Laboratory parameters included routine haematology, clinical chemistry, coagulation and urinalysis. With the exception of urinalysis and urine pregnancy test, which was performed as dip-stick analyses at the trial site, all laboratory tests were analysed by a central laboratory.
arm group label: PICOPREP day-before dosing schedule
arm group type: Active Comparator
description: Both doses administered the day before colonoscopy.
arm group label: PICOPREP tailored dosing schedule
arm group type: Experimental
description: First dose one day before colonoscopy or on the day of colonoscopy, dependent on the planned time for colonoscopy, and second dose on the day of colonoscopy.
intervention type: Drug
intervention name: PICOPREP
description: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
arm group label: PICOPREP day-before dosing schedule
arm group label: PICOPREP tailored dosing schedule
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Development Support
role: Study Director
affiliation: Ferring Pharmaceuticals
facility: 
facility: 
facility: 
country: France
country: Germany
country: Netherlands
responsible party type: Sponsor
mesh term: Picosulfate sodium
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 