Effect of PEG, Bisacodyl and Prucalopride on Colonic Motility in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT03279341|
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Constipation||Drug: polyethylene glycol Drug: Bisacodyl Drug: Prucalopride||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||open-label, randomized, reader-blinded, 3-period cross-over study|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
Active Comparator: bisacodyl, stimulant laxative
10 mg bisacodyl once daily oral administration with 125mL of water
Other Name: Dulcolax
Active Comparator: prucalopride, prokinetic
2mg prucalopride, film-coated tablets (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water
Other Name: Resolor
- 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)
- 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
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
|Leuven, Belgium, 3000|
|Principal Investigator:||Jan Tack, MD. PhD||KU Leuven|