Constipation Clinical Trial
Official title:
A Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of R108512 Tablets in Subjects With Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the
treatment of chronic constipation
Hypothesis:
Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the
treatment of patients with chronic constipation and is well tolerated in those patients
This is a multicentre, Phase III trial with a parallel-group design, consisting of a 2 week
drug-free run-in period, followed by a 12-week, double-blind, placebo-controlled treatment
period.
During the run-in period, the subject's bowel habit will be documented and the existence of
constipation confirmed. At the start of this period, all existing laxative medication will
be withdrawn and subjects will be instructed not to change their diet or lifestyle during
the trial. Subjects will be allowed to take a laxative (Dulcolax) as a rescue medication
throughout the trial, but only if they have not had a bowel movement for three or more
consecutive days. No Dulcolax or enemas should be taken within 48 hours prior to the start
of double-blind treatment and 48 hours following the start of double-blind treatment.
Subjects will enter the double-blind period if constipation is shown to be present during
the run-in period.
If the definition of constipation is not met during the 2-week run-in, the subject will be
considered ineligible for the double-blind period and will be discontinued from the study.
During the double-blind, randomised, placebo-controlled period, subjects will be treated for
12 weeks with either 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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