Expired Study
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Anaheim, California 92801


Purpose:

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).


Study summary:

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).


Criteria:

Inclusion Criteria: - completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL Exclusion Criteria: - Subjects who are pregnant or breastfeeding


NCT ID:

NCT00607971


Primary Contact:

Principal Investigator
Anthony Lembo, MD
Beth Israel Deaconess Medical Center, Boston


Backup Contact:

N/A


Location Contact:

Anaheim, California 92801
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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