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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alizyme
• Treatments: Renzapride

Criteria

Inclusion Criteria:

• completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Exclusion Criteria:

• Subjects who are pregnant or breastfeeding