NCT00487422

Efficacy and Safety Study of Prucalopride for the Treatment of Elderly Patients With Chronic Constipation

A Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Quality-of-Life of R108512 Tablets in Elderly Subjects With Chronic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether prucalopride is safe and effective in the treatment of chronic constipation in elderly patients. Hypothesis: Prucalopride 2 mg and 4 mg given once daily for 12 weeks is superior to placebo for the treatment of patients with chronic constipation and is well tolerated in those patients

Detailed description

This is a multicentre, randomised, 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. During the run-in period, the subject's bowel habit will be documented and the existence of constipation confirmed. At the start of this period, all existing laxative medication will be withdrawn and subjects will be instructed not to change their diet or lifestyle during the trial. Subjects will be allowed to take a laxative (Dulcolax®) as a rescue medication throughout the trial, but only if they have not had a bowel movement for three or more consecutive days. Subjects will enter the double-blind period if constipation is shown to be present during the run-in period. Patients will be randomly allocated to one of the 4 treatment arms: 1 mg, 2 mg, 4 mg of R108512 or placebo, with a 25% chance to each treatment group. During the double-blind period, subjects will be treated for 4 weeks with either 1 mg, 2 mg or 4 mg R108512 or placebo, given once daily before breakfast.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	2 mg o.d.
DRUG	Prucalopride	4 mg o.d.
OTHER	Placebo	o.d.

Timeline

• Start date: 1998-10-01
• Primary completion: 1999-09-01
• Completion: 1999-09-01
• First posted: 2007-06-18
• Last updated: 2008-05-29