Status:
TERMINATED
Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
Lead Sponsor:
Alizyme
Conditions:
Constipation-Predominant Irritable Bowel Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 bowe...
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...
Eligibility Criteria
Inclusion
- completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
Exclusion
- Subjects who are pregnant or breastfeeding
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
939 Patients enrolled
Trial Details
Trial ID
NCT00607971
Start Date
April 1 2006
End Date
June 1 2008
Last Update
July 8 2008
Active Locations (126)
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1
Research Site
Huntsville, Alabama, United States, 35801
2
Research Site
Chandler, Arizona, United States, 85225
3
Research Site
Phoenix, Arizona, United States, 85014
4
Research Site
Sierra Vista, Arizona, United States, 85635