<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/NCT04483037</url>
  </required_header>
  <id_info>
    <org_study_id>CCH IRB No.: 181216</org_study_id>
    <nct_id>NCT04483037</nct_id>
  </id_info>
  <brief_title>Different Dosing Time of Bowklean for the Bowel Preparation</brief_title>
  <official_title>Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhua Christian Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhua Christian Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to compare the efficacy of administration routine&#xD;
      bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior&#xD;
      Colonoscopy in the morning or in the afternoon.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with&#xD;
      similar efficacy and better tolerability than polyethylene glycol. However, there was limited&#xD;
      data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose&#xD;
      preparation for afternoon colonoscopy.&#xD;
&#xD;
      This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day&#xD;
      (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy.&#xD;
      One additional prospective observation group of 100 subjects receiving colonoscopy in the&#xD;
      morning was included as an observation group to compare bowel preparation in morning and&#xD;
      afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale,&#xD;
      Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble&#xD;
      Scale (TBS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Aronchick Scale Bowel Cleaning Scale</measure>
    <time_frame>during colonoscopy</time_frame>
    <description>Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale</measure>
    <time_frame>During Colonoscopy</time_frame>
    <description>The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colonscopy Bubble Scale</measure>
    <time_frame>During Colonoscopy</time_frame>
    <description>Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">297</enrollment>
  <condition>Bowel Preparation</condition>
  <arm_group>
    <arm_group_label>split dose, day before, colonoscopy in the morning (Observation Group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>routine bowel preparation before colonoscopy in the morning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>split dose, day before, colonoscopy in the afternoon (Random)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>routine bowel preparation before colonoscopy in the afternoon</description>
  </arm_group>
  <arm_group>
    <arm_group_label>two dose in the same day, colonoscopy in the afternoon (Random)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>experimental group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bowklean</intervention_name>
    <description>assigned intervention</description>
    <arm_group_label>split dose, day before, colonoscopy in the afternoon (Random)</arm_group_label>
    <arm_group_label>split dose, day before, colonoscopy in the morning (Observation Group)</arm_group_label>
    <arm_group_label>two dose in the same day, colonoscopy in the afternoon (Random)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 20 and 99 years, inclusive.&#xD;
&#xD;
          2. Men or non-pregnant women who are scheduled for an elective colonoscopy.&#xD;
&#xD;
          3. Subjects should be willing, able to complete the entire procedure and to comply with&#xD;
             study instructions.&#xD;
&#xD;
          4. Written informed consent obtained prior to study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are not suitable for colonoscopy&#xD;
&#xD;
               -  Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)&#xD;
&#xD;
               -  Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease&#xD;
                  (IBD)&#xD;
&#xD;
               -  Colon disease (history of colonic cancer, toxic megacolon, toxic colitis,&#xD;
                  idiopathic pseudo- obstruction, hypomotility syndrome)&#xD;
&#xD;
               -  Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention,&#xD;
                  gastroparesis, ileus)&#xD;
&#xD;
               -  Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before&#xD;
                  randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or&#xD;
                  uncontrolled hypertension&#xD;
&#xD;
               -  Renal insufficiency&#xD;
&#xD;
          2. Any prior colorectal surgery&#xD;
&#xD;
               -  in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior&#xD;
                  endoscopic procedures&#xD;
&#xD;
               -  History of upper gastrointestinal surgery (gastric resection, gastric banding,&#xD;
                  gastric by-pass)&#xD;
&#xD;
          3. Severe chronic constipation&#xD;
&#xD;
          4. Hypersensitivity to any ingredient in the study medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HsuHeng Yen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Changhua Christian Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hsu-Heng Yen</name>
      <address>
        <city>Changhua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 19, 2021</last_update_submitted>
  <last_update_submitted_qc>July 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhua Christian Hospital</investigator_affiliation>
    <investigator_full_name>HSUHENG YEN</investigator_full_name>
    <investigator_title>Head of Endoscopy Room</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04483037
org study id: CCH IRB No.: 181216
nct id: NCT04483037
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to compare the efficacy of administration routine
      bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior
      Colonoscopy in the morning or in the afternoon.
Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with
      similar efficacy and better tolerability than polyethylene glycol. However, there was limited
      data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose
      preparation for afternoon colonoscopy.

      This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day
      (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy.
      One additional prospective observation group of 100 subjects receiving colonoscopy in the
      morning was included as an observation group to compare bowel preparation in morning and
      afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale,
      Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble
      Scale (TBS).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
primary purpose: Other
masking: None (Open Label)
measure: Aronchick Scale Bowel Cleaning Scale
time frame: during colonoscopy
description: Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed
measure: Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale
time frame: During Colonoscopy
description: The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3
measure: Colonscopy Bubble Scale
time frame: During Colonoscopy
description: Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst.
arm group label: split dose, day before, colonoscopy in the morning (Observation Group)
arm group type: Active Comparator
description: routine bowel preparation before colonoscopy in the morning
arm group label: split dose, day before, colonoscopy in the afternoon (Random)
arm group type: Active Comparator
description: routine bowel preparation before colonoscopy in the afternoon
arm group label: two dose in the same day, colonoscopy in the afternoon (Random)
arm group type: Experimental
description: experimental group
intervention type: Drug
intervention name: Bowklean
description: assigned intervention
arm group label: split dose, day before, colonoscopy in the afternoon (Random)
arm group label: split dose, day before, colonoscopy in the morning (Observation Group)
arm group label: two dose in the same day, colonoscopy in the afternoon (Random)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: HsuHeng Yen, MD
role: Principal Investigator
affiliation: Changhua Christian Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Changhua Christian Hospital
investigator full name: HSUHENG YEN
investigator title: Head of Endoscopy Room
sharing ipd: No