Constipation Clinical Trial
Official title:
A Two-Period, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of re-Treatment of Prucalopride on Efficacy and Safety in Subjects With Chronic Constipation.
The purpose of this study is to determine whether prucalopride is safe and effective in the
re-treatment of chronic constipation.
Hypothesis:
Retreatment is as effective and safe as treatment with prucalopride in patients with chronic
constipation.
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 4-week double-blind, placebo-controlled treatment
period, a drug-free washout period of at least 2 weeks, and a second 4-week double-blind
treatment period.
During the initial run-in period, the subject's bowel habit will be documented in a daily
diary and the existence of constipation will be confirmed. Eligible subjects will be
randomly allocated to double-blind treatment with either 4 mg prucalopride or placebo, given
orally once daily before breakfast, for 4 weeks.
After 4 weeks of treatment, each subject will enter a drug-free washout period. The length
of the washout period will be either 2 or 4 weeks, depending on how long it takes for the
subject to meet the criteria for constipation. If the subject is unable to re-qualify after
a 4-week washout, the subject must be discontinued from the trial.
Subjects who qualify for the second double-blind treatment period will receive the same
treatment as during the first treatment period, once-daily for an additional four weeks.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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