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

Sponsor

University Hospital, Gasthuisberg (Other)

Overall Status

Completed

CT.gov ID

NCT03279341

Collaborator

(none)

Enrollment

Location

Arms

38.9

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

open-label, randomized, reader-blinded, 3-period cross-over studyopen-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 :

Dec 3, 2012

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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 Names: 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 Names: Resolor

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 Names:

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 Names:

Resolor

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

association between motility parameters and number and consistency of bowel movements in healthy subjects [during a 12-hour intraluminal manometry]
number of colonic motor patterns and number of bowel movements and stool consistency assessed by Bristol Stool Chart

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	TARGID	Leuven		Belgium	3000

Sponsors and Collaborators

University Hospital, Gasthuisberg

Investigators

Principal Investigator: Jan Tack, MD. PhD, KU Leuven

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maura Corsetti, Associate Professor of Gastroenterology, University Hospital, Gasthuisberg

ClinicalTrials.gov Identifier:

NCT03279341

Other Study ID Numbers:

S54750

First Posted:

Sep 12, 2017

Last Update Posted:

Sep 12, 2017

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Maura Corsetti, Associate Professor of Gastroenterology, University Hospital, Gasthuisberg

laxatives

constipation

Additional relevant MeSH terms:

Constipation

Prucalopride

Bisacodyl

Study Results

No Results Posted as of Sep 12, 2017