<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/NCT03248726</url>
  </required_header>
  <id_info>
    <org_study_id>N201610042</org_study_id>
    <nct_id>NCT03248726</nct_id>
  </id_info>
  <brief_title>Comparing Single-dose Low-volume PEG Plus Bisacodyl vs. Split-dose PEG for Bowel Preparation in Morning Colonoscopy</brief_title>
  <official_title>Comparison of Single-dose (Morning) Low-volume Polyethylene Glycol Plus Bisacodyl Versus Split-dose Polyethylene Glycol for Bowel Preparation Efficacy in Patient Receiving Morning Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University WanFang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University WanFang 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>
      Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed&#xD;
      that adenoma detection rate positive correlation with good bowel preparation which makes&#xD;
      bowel preparation an important issue. Hence, investigators conduct a clinical trial about&#xD;
      adding another laxative agent to morning single dose low-volume PEG. To see if this new&#xD;
      regimen could have non-inferior efficacy and lower life/sleep impact compared with standard&#xD;
      regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has&#xD;
      come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to&#xD;
      detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate&#xD;
      positive correlation with good bowel preparation. That makes bowel preparation an important&#xD;
      issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and&#xD;
      safety. However, there are many different adjunctive, dose, timing of administration in PEG&#xD;
      preparation. Some may decrease patient tolerability due to large fluid volume, and some may&#xD;
      influence patient's life and sleep quality when performing bowel preparation. Here,&#xD;
      investigators conduct a clinical trial about adding another laxative agent to morning single&#xD;
      dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower&#xD;
      life/sleep impact compared with standard regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2017</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Ottawa Bowel Preparation Scale</measure>
    <time_frame>Within 24 hours after colonoscopy</time_frame>
    <description>Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as &quot;good preparation&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life disturbance</measure>
    <time_frame>30 minutes before patient receive colonoscopy</time_frame>
    <description>Evaluate patients life disturbance with a questionnaire before performing a colonoscopy. The questionnaire including side effect, sleep quality, interference of life/work, and tendency of same bowel preparation method at next colonoscopy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Bowel Preparation</condition>
  <arm_group>
    <arm_group_label>Polyethylene glycol and bisacodyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Split-dose polyethylene glycol</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination .</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene glycol and bisacodyl</intervention_name>
    <description>Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.</description>
    <arm_group_label>Polyethylene glycol and bisacodyl</arm_group_label>
    <other_name>Dulcolax®</other_name>
    <other_name>Klean-prep®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Split-dose polyethylene glycol</intervention_name>
    <description>Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.</description>
    <arm_group_label>Split-dose polyethylene glycol</arm_group_label>
    <other_name>Klean-prep®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 20-70 years.&#xD;
&#xD;
          -  Out-patient department ambulatory patient.&#xD;
&#xD;
          -  Patients who have indications to receive colonoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age is under 20 or over 70&#xD;
&#xD;
          -  Have severe renal impairment (hemodialysis or eGFR&lt;30).&#xD;
&#xD;
          -  Have severe congestive heart failure (NYHAⅢorⅣ).&#xD;
&#xD;
          -  Pregnant or lactating, or women is under oral contraceptive.&#xD;
&#xD;
          -  Have history of bowel obstruction or resection, known or suspected gastroparesis acute&#xD;
             gastric/intestinal ulcer, toxic colitis or megacolon&#xD;
&#xD;
          -  Be allergic to polyethylene glycol (PEG) or bisacodyl.&#xD;
&#xD;
          -  Have severe constipation ( ≤ 1 bowel movement per week).&#xD;
&#xD;
          -  Patient who has Phenylketonuria.&#xD;
&#xD;
          -  Refuse to sign consent to the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wei-Cheng Huang, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gastroenterology division, Internal Medicine Department, Wanfang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wanfang Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>116</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>May 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>October 28, 2019</last_update_submitted>
  <last_update_submitted_qc>October 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyethylene Glycol</keyword>
  <keyword>Bisacodyl</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Bowel preparation</keyword>
  <keyword>Ottawa bowel preparation scale</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bisacodyl</mesh_term>
  </intervention_browse>
  <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/NCT03248726
org study id: N201610042
nct id: NCT03248726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colonoscopy is the best method to detect colorectal cancer and colonic polyps. Studies showed
      that adenoma detection rate positive correlation with good bowel preparation which makes
      bowel preparation an important issue. Hence, investigators conduct a clinical trial about
      adding another laxative agent to morning single dose low-volume PEG. To see if this new
      regimen could have non-inferior efficacy and lower life/sleep impact compared with standard
      regimen.
Colorectal cancer incidence rate has increased in recently years, and colorectal cancer has
      come to the top of cancer incidence ranking of Taiwan. Colonoscopy is the best method to
      detect colorectal cancer and colonic polyps. Studies showed that adenoma detection rate
      positive correlation with good bowel preparation. That makes bowel preparation an important
      issue. Polyethylene Glycol (PEG) is widely used for bowel preparation for it efficacy and
      safety. However, there are many different adjunctive, dose, timing of administration in PEG
      preparation. Some may decrease patient tolerability due to large fluid volume, and some may
      influence patient's life and sleep quality when performing bowel preparation. Here,
      investigators conduct a clinical trial about adding another laxative agent to morning single
      dose low-volume PEG. To see if this new regimen could have non-inferior efficacy and lower
      life/sleep impact compared with standard regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: The Ottawa Bowel Preparation Scale
time frame: Within 24 hours after colonoscopy
description: Examiner will fill a case report form out after performing a colonoscopy. Score below or equal to 6 will be classified as "good preparation".
measure: Life disturbance
time frame: 30 minutes before patient receive colonoscopy
description: Evaluate patients life disturbance with a questionnaire before performing a colonoscopy. The questionnaire including side effect, sleep quality, interference of life/work, and tendency of same bowel preparation method at next colonoscopy.
arm group label: Polyethylene glycol and bisacodyl
arm group type: Experimental
description: In order to decrease the dose and frequency of polyethylene glycol, we added bisacodyl at the night before examination to facilitate the action of polyethylene glycol given solely in the morning of examination.
arm group label: Split-dose polyethylene glycol
arm group type: Active Comparator
description: The standard regimen of polyethylene glycol was used in this group. The participant of this arm receives polyethylene glycol in the evening before examination and the morning of examination .
intervention type: Drug
intervention name: Polyethylene glycol and bisacodyl
description: Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.
arm group label: Polyethylene glycol and bisacodyl
other name: Dulcolax®
other name: Klean-prep®
intervention type: Drug
intervention name: Split-dose polyethylene glycol
description: Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.
arm group label: Split-dose polyethylene glycol
other name: Klean-prep®
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Wei-Cheng Huang, Bachelor
role: Principal Investigator
affiliation: Gastroenterology division, Internal Medicine Department, Wanfang Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Bisacodyl
sharing ipd: No