Constipation Clinical Trial
Official title:
Study to Evaluate the Effect of a 1 mg o.d. Dose of Prucalopride in Patients With Chronic Idiopathic Constipation
The purpose of this study is to determine whether prucalopride is safe and effective in the
treatment of chronic idiopathic constipation.
Hypothesis:
Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic
constipation shows a favourable effect on most of the efficacy parameters assessed in this
trial. This dosage can be considered safe and generally well-tolerated.
This is a randomized, double-blind, placebo-controlled, parallel-group, phase II trial set up to investigate the efficacy, safety and physiological effects of prucalopride 1 mg administered o.d. for 4 weeks to female patients with chronic idiopathic constipation. The primary objective of this trial was to assess the effect of prucalopride 1 mg on whole gut transit (measured as changes from baseline in total number of markers). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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