Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
- Conditions
- Constipation-Predominant Irritable Bowel Syndrome
- Interventions
- Registration Number
- NCT00607971
- Lead Sponsor
- Alizyme
- 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 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 939
- completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
- Subjects who are pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 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
- Primary Outcome Measures
Name Time Method Adverse events One year
- Secondary Outcome Measures
Name Time Method Vital signs, routine clinical laboratory data, 12-lead ECG One year
Trial Locations
- Locations (1)
Research Site
🇺🇸Milwaukee, Wisconsin, United States