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

Phase 3
Terminated
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
Inclusion Criteria
  • completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
Exclusion Criteria
  • Subjects who are pregnant or breastfeeding

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1RenzaprideAll 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
NameTimeMethod
Adverse eventsOne year
Secondary Outcome Measures
NameTimeMethod
Vital signs, routine clinical laboratory data, 12-lead ECGOne year

Trial Locations

Locations (1)

Research Site

🇺🇸

Milwaukee, Wisconsin, United States

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