Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation|
- Constipation severity (VAS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Stool frequency (stool/week) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 1994|
|Study Completion Date:||February 1996|
|Primary Completion Date:||February 1996 (Final data collection date for primary outcome measure)|
Active Comparator: 1
4 mg o.d.
Other Name: Resolor
|Placebo Comparator: 2||
This is a phase II trial with a parallel-group design, consisting of a run-in phase (phase I), followed by a placebo controlled double-blind phase (phase 2). Patients will receive either R093877 4 mg or placebo o.d. for a period of 4 weeks.
Phase 1 is a run-in period of 4 weeks duration, during which the bowel habit is documented and the existence of constipation determined. If the definition of constipation was not met during the 4 weeks of the run-in period, double-blind treatment will not be started.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be treated for 4 weeks with either 4 mg of R093877 or placebo given o.d. (two capsules of 2 mg are taken before breakfast).