NCT00268879

Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS)

A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,821 (actual)
• Sponsor: Alizyme · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Detailed description

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function. In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Renzapride	Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2005-12-23
• Last updated: 2008-02-15

Locations

1 site across 1 country: United Kingdom