NCT00576511

Effect of Prucalopride in Patients With Severe Chronic Idiopathic Constipation

A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of R093877 in Patients With Severe Chronic Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether prucalopride is safe and effective in patients with severe chronic constipation.

Detailed description

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).

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	4 mg o.d.
DRUG	placebo	Placebo o.d.

Timeline

• Start date: 1994-12-01
• Primary completion: 1996-02-01
• Completion: 1996-02-01
• First posted: 2007-12-19
• Last updated: 2008-05-29