Constipation Clinical Trial
Official title:
A Double-Blind Placebo-Controlled Dose-Finding Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Chronic Idiopathic Constipation
The purpose of this study is to determine which dose of prucalopride is safe and effective
in patients with chronic idiopathic constipation.
Hypothesis:
Prucalopride 1 and 2 mg are safe and effective for the treatment of chronic idiopathic
constipation whereas 0,5 mg is a suboptimal dose.
This is a phase II trial with a parallel-group design, consisting of a drug-free run-in
phase (phase 1), followed by a placebo controlled double-blind phase (phase 2). Patients
will receive either R093877 0.5 mg o.d., 1 mg o.d. or 2 mg o.d. or placebo 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 confirmed. At the start of this period all existing
laxative medication is withdrawn but patients will be instructed not to change their dietary
habits, in particular their fibre intake during the trial. Patients will enter the
double-blind phase if constipation has been shown to be present during the run-in period.
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 0.5 mg, 1 mg or 2 mg of R093877 or placebo given once daily
(one capsule is taken before breakfast).
Patients admitted to the double blind treatment period will be randomly allocated to one of
the 4 treatment arms.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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