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

NCT03279341 | Completed Phase 4

• 1 other identifier: S54750
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Constipation

Keywords

laxatives; constipation

Outcome Measures

Primary Outcomes (1)

• colonic motor patterns during PEG, bisacodyl and prucalopride in healthy subjects.

  number of colonic high amplitude propagated contractions (HAPCs)

  during a 12-hour intraluminal manometry

Secondary Outcomes (1)

• association between motility parameters and number and consistency of bowel movements in healthy subjects

  during a 12-hour intraluminal manometry

Study Arms (3)

polyethylene glycol, osmotic laxitive

ACTIVE COMPARATOR

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

bisacodyl, stimulant laxative

ACTIVE COMPARATOR

10 mg bisacodyl once daily oral administration with 125mL of water

Drug: Bisacodyl

prucalopride, prokinetic

ACTIVE COMPARATOR

2mg prucalopride, film-coated tablets (prucalopride succinate eq. 2mg), once daily oral administration with 125mL of water

Drug: Prucalopride

Interventions

polyethylene glycol DRUG

osmotic laxative

Also known as: macrogol, PEG

polyethylene glycol, osmotic laxitive

Bisacodyl DRUG

stimulant laxative

Also known as: Dulcolax

bisacodyl, stimulant laxative

Prucalopride DRUG

prokinetic

Also known as: Resolor

prucalopride, prokinetic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy male and non-pregnant, non-breastfeeding female participants, aged 18-65 years old at the time of consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (1)

TARGID

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Constipation

Interventions

Polyethylene Glycols; Bisacodyl; prucalopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Cresols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jan Tack, MD. PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Gastroenterology

Model Details: open-label, randomized, reader-blinded, 3-period cross-over study

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: September 12, 2017
• Study Start: December 3, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 12, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)