<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/NCT03279341</url>
  </required_header>
  <id_info>
    <org_study_id>S54750</org_study_id>
    <nct_id>NCT03279341</nct_id>
  </id_info>
  <brief_title>Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects</brief_title>
  <official_title>An Open-label, Randomised, Crossover, Reader Blinded, Study to Compare the Effect of Polyethylene Glycol 3350, Bisacodyl and Prucalopride on Colonic Motility Assessed With Intraluminal Colonic Manometry in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Gasthuisberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Gasthuisberg</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aim was to evaluate the effect of pharmacological treatments normally used to&#xD;
      treat functional constipation and in particular PEG, bisacodyl and prucalopride on colonic&#xD;
      motility as assessed by high-resolution manometry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: Several treatments with different modes of action are currently available for&#xD;
      chronic constipation. This study will investigate the effect of these different modes of&#xD;
      actions of PEG 3350 + electrolytes, bysacodyl and prucalopride and on colonic motility&#xD;
      parameters (e.g. HAPC).&#xD;
&#xD;
      Objectives:Primary: to compare and determine the effects of PEG, bisacodyl and prucalopride&#xD;
      on the number of colonic high amplitude propagated contractions (HAPCs) during a 12-hour&#xD;
      intraluminal manometry in healthy subjects. Secondary: to evaluate the association between&#xD;
      motility parameters and number and consistency of bowel movements in healthy subjects.&#xD;
&#xD;
      Investigational product, dose, and mode of administration: Regimen A: 13.8g polyethylene&#xD;
      glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with&#xD;
      125mL of water administered twice orally as a solution. Regimen B: 10 mg bisacodyl once daily&#xD;
      oral administration with 125mL of water. Regimen C: 2mg prucalopride, film-coated tablets&#xD;
      (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water.&#xD;
&#xD;
      Methodology: This is an open-label, randomized, reader-blinded, 3-period cross-over study&#xD;
      investigating the effects of PEG 3350 + electrolytes, bisacodyl and prucalopride on colon&#xD;
      motility with intraluminal manometry. On day 1 of each Treatment Period, a manometry catheter&#xD;
      will be placed in the colon under conscious sedation and the colonic pressure will be&#xD;
      continuously measured through 12 hours after administration of each of the investigational&#xD;
      products (Regimen A, B or C).&#xD;
&#xD;
      Inclusion criteria: healthy male and non-pregnant, non-breastfeeding female participants,&#xD;
      aged 18-65 years old at the time of consent. Exclusion criteria: use of medications within 48&#xD;
      h of dose initiation; structural or metabolic diseases that affect the gastrointestinal&#xD;
      system and functional gastrointestinal disorders; previous abdominal surgery other than&#xD;
      appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as&#xD;
      diabetes, cardiovascular or lung disease; use of agents that influence bowel habit, i.e.&#xD;
      anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics&#xD;
      and prokinetics in the 7 days before the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 3, 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Crossover Assignment</intervention_model>
    <intervention_model_description>open-label, randomized, reader-blinded, 3-period cross-over study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>colonic motor patterns during PEG, bisacodyl and prucalopride in healthy subjects.</measure>
    <time_frame>during a 12-hour intraluminal manometry</time_frame>
    <description>number of colonic high amplitude propagated contractions (HAPCs)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>association between motility parameters and number and consistency of bowel movements in healthy subjects</measure>
    <time_frame>during a 12-hour intraluminal manometry</time_frame>
    <description>number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Chronic Constipation</condition>
  <arm_group>
    <arm_group_label>polyethylene glycol, osmotic laxitive</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>13.8g polyethylene glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with 125mL of water administered twice orally as a solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bisacodyl, stimulant laxative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 mg bisacodyl once daily oral administration with 125mL of water</description>
  </arm_group>
  <arm_group>
    <arm_group_label>prucalopride, prokinetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2mg prucalopride, film-coated tablets (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>polyethylene glycol</intervention_name>
    <description>osmotic laxative</description>
    <arm_group_label>polyethylene glycol, osmotic laxitive</arm_group_label>
    <other_name>macrogol</other_name>
    <other_name>PEG</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bisacodyl</intervention_name>
    <description>stimulant laxative</description>
    <arm_group_label>bisacodyl, stimulant laxative</arm_group_label>
    <other_name>Dulcolax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prucalopride</intervention_name>
    <description>prokinetic</description>
    <arm_group_label>prucalopride, prokinetic</arm_group_label>
    <other_name>Resolor</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years&#xD;
             old at the time of consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  use of medications within 48 h of dose initiation; structural or metabolic diseases&#xD;
             that affect the gastrointestinal system and functional gastrointestinal disorders;&#xD;
             previous abdominal surgery other than appendectomy, cholecystectomy, hysterectomy, or&#xD;
             hernia repair; known illnesses such as diabetes, cardiovascular or lung disease; use&#xD;
             of agents that influence bowel habit, i.e. anticholinergics (not including&#xD;
             antihistamines with anticholinergic properties), spasmolytics and prokinetics in the 7&#xD;
             days before the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan Tack, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TARGID</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Gasthuisberg</investigator_affiliation>
    <investigator_full_name>Maura Corsetti</investigator_full_name>
    <investigator_title>Associate Professor of Gastroenterology</investigator_title>
  </responsible_party>
  <keyword>laxatives</keyword>
  <keyword>constipation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prucalopride</mesh_term>
    <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/NCT03279341
org study id: S54750
nct id: NCT03279341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study aim was to evaluate the effect of pharmacological treatments normally used to
      treat functional constipation and in particular PEG, bisacodyl and prucalopride on colonic
      motility as assessed by high-resolution manometry.
Rationale: Several treatments with different modes of action are currently available for
      chronic constipation. This study will investigate the effect of these different modes of
      actions of PEG 3350 + electrolytes, bysacodyl and prucalopride and on colonic motility
      parameters (e.g. HAPC).

      Objectives:Primary: to compare and determine the effects of PEG, bisacodyl and prucalopride
      on the number of colonic high amplitude propagated contractions (HAPCs) during a 12-hour
      intraluminal manometry in healthy subjects. Secondary: to evaluate the association between
      motility parameters and number and consistency of bowel movements in healthy subjects.

      Investigational product, dose, and mode of administration: Regimen A: 13.8g polyethylene
      glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with
      125mL of water administered twice orally as a solution. Regimen B: 10 mg bisacodyl once daily
      oral administration with 125mL of water. Regimen C: 2mg prucalopride, film-coated tablets
      (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water.

      Methodology: This is an open-label, randomized, reader-blinded, 3-period cross-over study
      investigating the effects of PEG 3350 + electrolytes, bisacodyl and prucalopride on colon
      motility with intraluminal manometry. On day 1 of each Treatment Period, a manometry catheter
      will be placed in the colon under conscious sedation and the colonic pressure will be
      continuously measured through 12 hours after administration of each of the investigational
      products (Regimen A, B or C).

      Inclusion criteria: healthy male and non-pregnant, non-breastfeeding female participants,
      aged 18-65 years old at the time of consent. Exclusion criteria: use of medications within 48
      h of dose initiation; structural or metabolic diseases that affect the gastrointestinal
      system and functional gastrointestinal disorders; previous abdominal surgery other than
      appendectomy, cholecystectomy, hysterectomy, or hernia repair; known illnesses such as
      diabetes, cardiovascular or lung disease; use of agents that influence bowel habit, i.e.
      anticholinergics (not including antihistamines with anticholinergic properties), spasmolytics
      and prokinetics in the 7 days before the study.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: open-label, randomized, reader-blinded, 3-period cross-over study
primary purpose: Other
masking: Double (Investigator, Outcomes Assessor)
measure: colonic motor patterns during PEG, bisacodyl and prucalopride in healthy subjects.
time frame: during a 12-hour intraluminal manometry
description: number of colonic high amplitude propagated contractions (HAPCs)
measure: association between motility parameters and number and consistency of bowel movements in healthy subjects
time frame: during a 12-hour intraluminal manometry
description: number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart
arm group label: polyethylene glycol, osmotic laxitive
arm group type: Active Comparator
description: 13.8g polyethylene glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with 125mL of water administered twice orally as a solution
arm group label: bisacodyl, stimulant laxative
arm group type: Active Comparator
description: 10 mg bisacodyl once daily oral administration with 125mL of water
arm group label: prucalopride, prokinetic
arm group type: Active Comparator
description: 2mg prucalopride, film-coated tablets (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water
intervention type: Drug
intervention name: polyethylene glycol
description: osmotic laxative
arm group label: polyethylene glycol, osmotic laxitive
other name: macrogol
other name: PEG
intervention type: Drug
intervention name: Bisacodyl
description: stimulant laxative
arm group label: bisacodyl, stimulant laxative
other name: Dulcolax
intervention type: Drug
intervention name: Prucalopride
description: prokinetic
arm group label: prucalopride, prokinetic
other name: Resolor
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jan Tack, MD. PhD
role: Principal Investigator
affiliation: KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Gasthuisberg
investigator full name: Maura Corsetti
investigator title: Associate Professor of Gastroenterology
mesh term: Constipation
mesh term: Prucalopride
mesh term: Bisacodyl
sharing ipd: No