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Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279341
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Maura Corsetti, University Hospital, Gasthuisberg

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Constipation Drug: polyethylene glycol Drug: Bisacodyl Drug: Prucalopride Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: open-label, randomized, reader-blinded, 3-period cross-over study
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : December 3, 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Active Comparator: polyethylene glycol, osmotic laxitive
13.8g polyethylene glycol 3350 with sodium bicarbonate, sodium chloride, and potassium chloride, mixed with 125mL of water administered twice orally as a solution
Drug: polyethylene glycol
osmotic laxative
Other Names:
  • macrogol
  • PEG

Active Comparator: bisacodyl, stimulant laxative
10 mg bisacodyl once daily oral administration with 125mL of water
Drug: Bisacodyl
stimulant laxative
Other Name: Dulcolax

Active Comparator: prucalopride, prokinetic
2mg prucalopride, film-coated tablets (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water
Drug: Prucalopride
prokinetic
Other Name: Resolor




Primary Outcome Measures :
  1. colonic motor patterns during PEG, bisacodyl and prucalopride in healthy subjects. [ Time Frame: during a 12-hour intraluminal manometry ]
    number of colonic high amplitude propagated contractions (HAPCs)


Secondary Outcome Measures :
  1. association between motility parameters and number and consistency of bowel movements in healthy subjects [ Time Frame: during a 12-hour intraluminal manometry ]
    number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279341


Locations
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Belgium
TARGID
Leuven, Belgium, 3000
Sponsors and Collaborators
University Hospital, Gasthuisberg
Investigators
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Principal Investigator: Jan Tack, MD. PhD KU Leuven
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Responsible Party: Maura Corsetti, Associate Professor of Gastroenterology, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT03279341    
Other Study ID Numbers: S54750
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maura Corsetti, University Hospital, Gasthuisberg:
laxatives
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Prucalopride
Bisacodyl
Laxatives
Gastrointestinal Agents
Serotonin 5-HT4 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cathartics