Chronic Constipation Clinical Trial
Official title:
A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.
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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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