NCT00598338

Efficacy and Safety Study of Prucalopride for the Re-Treatment of Chronic Constipation

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Prucalopride	4 mg o.d.
OTHER	Placebo	o.d.

Timeline

• Start date: 1999-04-01
• Primary completion: 2000-02-01
• Completion: 2000-02-01
• First posted: 2008-01-21
• Last updated: 2008-05-29