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

NCT00607971 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 939

Last updated 2008-07-08

No results posted yet for this study

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).

Conditions

  • Constipation-Predominant Irritable Bowel Syndrome

Interventions

DRUG

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

Sponsors & Collaborators

  • Alizyme

    lead INDUSTRY

Principal Investigators

  • Anthony Lembo, MD · Beth Israel Deaconess Medical Center, Boston

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607971 on ClinicalTrials.gov