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 constipation.

Phase 3

Completed

Conditions: constipation
obstipation
10018008

Registration Number: NL-OMON39176

Lead Sponsor: Shire-Movetis NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 18

Inclusion Criteria

- subject is male out-patient >= 18 years of age.
- 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: - very hard (little balls) and/or hard stools for at least a quarter of the stools; - sensation of incomplete evacuation following for at least a quarter of the stoold; - straining at defecation for at least a quarter of the time. These criteria are only applicable for SBMs, i.e. BNs 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.
- Subject agrees to stop his current laxative treatment and is willing to use rescue medication according to the rescue rule (bisacodyl (Dulcolax) / enemas).

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion (%) of subjects with an average of >= 3 SCBMs/week (i.e. a responder)<br /><br>over the 12-week double-blind treatment period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Proportion (%) of subjects with an average increase of >= 1 SCBMs/week<br /><br>compared to the run-in period, over the entire treatment period.<br /><br>- The average number of (SC)BM/week and change from baseline<br /><br>- Number of (SC)BMs per week: descriptive statistics and distribution in<br /><br>categories as 0, (0;1), [1;2), [2;3), [3:*)<br /><br>- Consistency per (SC)BM: descriptive statistics of 7-point score and % (SC)BM<br /><br>with normal consistency (Type 3 or 4 on the Bristol stool scale).<br /><br>- For more secondary endpoints, please refer to the study protocol.</p><br>