NCT00577018

Efficacy and Safety Study of the Effect of Dose-Titration of Prucalopride for The Treatment of Chronic Constipation

A Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dose-Titration on the Safety and Efficacy and R108512 Tablets in Subjects With Chronic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety profile of 4 mg prucalopride in the treatment of chronic constipation.

Detailed description

To evaluate the potential differences in the adverse event (safety) profile between 4 mg of prucalopride daily for 4 weeks; titration up to a 4-mg total daily dose of prucalopride by starting at 1 mg for 2 days, 2 mg for 2 days, to 4 mg thereafter; and placebo given as oral tablets once daily for 4 weeks in patients with chronic constipation

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	Prucalopride	4 mg o.d.
DRUG	Prucalopride	1 mg o.d. for 2 days, 2 mg o.d. for 2 days and 4 mg o.d. thereafter
OTHER	Placebo	o.d.

Timeline

• Start date: 1998-08-01
• Primary completion: 1999-09-01
• Completion: 1999-09-01
• First posted: 2007-12-19
• Last updated: 2008-05-29