A study to evaluate the efficacy, quality of life, side effects and tolerability of long term treatment (12 weeks) with prucalopride in male patients aged =18 years with chronic constipatio

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 348

Inclusion Criteria

Main inclusion criteria to be assessed at screening:
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 that result in a feeling of complete evacuation (SCBM) 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 current laxative treatment and is willing to use rescue.

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.* medication according to the rescue rule [Dulcolax® (bisacodyl)/ enemas].
3. Subject did not use disallowed medication during the run-in period.
* Excluding the first 7 days for subjects using medication influencing bowel habit or excluding the days between screening and the 7 days following the colonoscopy/sigmoidoscopy for those who had a colonoscopy/sigmoidoscopy after screening.
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 334
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

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 =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 non-responder for the primary analysis.<br>The Cochran-Mantel-Haenszel test controlling for the randomisation stratification factors (country and CBM) will be used to compare treatment groups.<br>;Timepoint(s) of evaluation of this end point: The key evaluation period will be the 24-week double-blind treatment phase. This endpoint will also be evaluated in periods of 4 weeks and per week of treatment

Secondary Outcome Measures

Name	Time	Method

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