NCT00575614

Prucalopride in Patients With Chronic Idiopathic Constipation

Study to Evaluate the Effect of a 1 mg o.d. Dose of Prucalopride in Patients With Chronic Idiopathic Constipation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Movetis · Industry
• Sex: Female
• Age: 18 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 idiopathic constipation. Hypothesis: Prucalopride given at a dose of 1 mg o.d. for 4 weeks to female patients with chronic constipation shows a favourable effect on most of the efficacy parameters assessed in this trial. This dosage can be considered safe and generally well-tolerated.

Detailed description

This is a randomized, double-blind, placebo-controlled, parallel-group, phase II trial set up to investigate the efficacy, safety and physiological effects of prucalopride 1 mg administered o.d. for 4 weeks to female patients with chronic idiopathic constipation. The primary objective of this trial was to assess the effect of prucalopride 1 mg on whole gut transit (measured as changes from baseline in total number of markers).

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	1 mg o.d.
DRUG	placebo	o.d.

Timeline

• Start date: 1997-04-01
• Primary completion: 1999-03-01
• Completion: 1999-03-01
• First posted: 2007-12-18
• Last updated: 2008-05-29