A 12-week, randomised, double-blind, placebo controlled trial to evaluate the efficacy, quality of life, safety and tolerability of prucalopride in male subjects with chronic constipatio

Phase 1

• Conditions: Chronic constipation; MedDRA version: 12.1Level: LLTClassification code 10063582Term: Constipation chronic

• Registration Number: EUCTR2009-015719-42-FR
• Lead Sponsor: Movetis NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-22
• Study Completion: 2013-10-25
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 374

Inclusion Criteria

1. Subject is a male out-patient =18 years of age (no upper age limit).
2. Subject has a history of constipation, i.e. reports an average of =2 spontaneous
bowel movements (SBM)/week and one or more of the following for at least 6
months before the selection visit:
a) Very hard (little balls) and/or hard stools for at least a quarter of the stools;
b) Sensation of incomplete evacuation following for at least a quarter of
stools;
c) Straining at defecation for at least a quarter of the time.
The above criteria are only applicable for SBMs, i.e. BMs not preceded within
a period of 24 hours by the intake of a laxative agent or by the use of an enema.
Subjects who never have SBMs are considered to be constipated and are
eligible for the trial.
3. Subject agrees to stop his/her current laxative treatment and is willing to use
rescue medication according to the rescue rule [Dulcolax??(bisacodyl)/
enemas].
Main inclusion criteria to be assessed at baseline (randomisation):
1. During the run-in period, the subject reports an average of =2 SBM/week that
result in a feeling of complete evacuation (SCBM).*
This includes subjects who never have SBMs.
2. Subject stopped his/her laxative treatment and did not use rescue mediation on
more than 75% of days during the run-in period.*
3. Subject did not use disallowed medication during the run-in period.
* Excluding the first 7 days for subjects using medication influencing bowel habit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects in whom constipation is thought to be drug-induced.
2. Subjects using any disallowed medication.
3. Subjects suffering from secondary causes of chronic constipation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation;Secondary Objective: To evaluate the safety, tolerability, effect on quality of life and effect on symptoms of prucalopride versus placebo over 12 weeks of treatment in male subjects with chronic constipation;Primary end point(s): The primary parameter is the proportion (%) of subjects with an average of<br>=3 SCBMs/week (i.e. a responder) over the 12-week double-blind treatment period.<br>If e-diary data are available for less than 28 days, the subject will be considered a<br>non-responder for the primary analysis.<br>The Cochran-Mantel-Haenszel test controlling for the randomisation stratification<br>factors (country and CBM) will be used to compare treatment groups.<br>