Constipation Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Efficacy and Safety of Prucalopride (R093877) in Subjects With Chronic Idiopathic Constipation
The purpose of the study is to determine whether prucalopride is safe and effective in
patients with chronic idiopathic constipation.
Hypothesis:
At all doses administered prucalopride given once daily for 4 weeks is safe and well
tolerated in patients with chronic idiopathic constipation.
This was a double-blind, placebo-controlled, randomized, parallel group, multicentre, Phase
II, dose comparison trial, in which 313 subjects, with a history of chronic idiopathic
constipation were enrolled. The trial was conducted in three phases:
1. a 4-week drug-free run-in phase,
2. a 4-week double-blind (DB) phase during which subjects were treated with R093877 (0.5
mg, 1 mg, 2 mg, or 4 mg capsule) or matching placebo once daily, prior to breakfast,
3. a 4-week drug-free run-out phase (RO).
To qualify for the run-in phase (Visit 1, Week 1) subjects had to have experienced, for at
least 3 months, 2 or less spontaneous, bowel movements (SBM)/week with the occurrence of
lumpy (scyballae) and/or hard stools, a sensation of incomplete evacuation for at least a
quarter of their stools, or straining during defecation at least a quarter of the time.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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