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 constipation.
Hypothesis:
Prucalopride 1 and 2 mg bid are safe and effective for the treatment of chronic 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 b.i.d., 1 mg b.i.d. or 2 mg b.i.d. or placebo for a
period of 12 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laxative medication is withdrawn and patients will be instructed not to change their dietary
habits, in particular their fiber 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, the
patient will be considered ineligible for the double-blind period.
Phase 2 is a double-blind, randomized, placebo-controlled phase, in which patients will be
treated for 12 weeks with either 0.5 mg, 1 mg or 2 mg of R093877 or placebo given twice
daily (one capsule is taken before breakfast and one is to be taken before the evening
meal).
Patients admitted to the double blind treatment period will be randomly allocated to one of
the 4 treatment arms.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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