NCT00607971

Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 939 (actual)
• Sponsor: Alizyme · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the long-term safety and tolerability of renzapride at a dose of 4 mg taken once daily for 12 months in women with constipation-predominant irritable bowel syndrome (IBS-C).

Detailed description

Since IBS is a chronic condition affecting patients over many years, it is anticipated that renzapride will be prescribed and used by patients on a daily basis for long periods of time. Hence the need to understand its long-term safety and tolerability in the target population. This study is open label and so all subjects will take renzapride and will know that they are taking it. Enrolment in to this study is restricted to subjects completing a 12-week, placebo-controlled study of the effectiveness of renzapride in providing relief from IBS-C (Study no. ATL1251/038/CL).

Conditions

• Constipation-Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Renzapride	All subjects take two capsules (2x renzapride 2 mg) daily, from the day of enrolment until the scheduled visit at the end of Week 52

Timeline

• Start date: 2006-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2008-02-06
• Last updated: 2008-07-08

Locations

126 sites across 1 country: United States