NCT00631813

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 At the start of this period all existing laxative medication is withdrawn and patients will be instructed not to change their dietary habits, in particular their fiber intake during the trial.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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Prucalopride	0.5 mg bid
DRUG	Prucalopride	1 mg bid
DRUG	Prucalopride	2 mg bid
DRUG	Placebo	bid

Timeline

• Start date: 1995-11-01
• Primary completion: 1997-04-01
• Completion: 1997-04-01
• First posted: 2008-03-10
• Last updated: 2008-05-29