Long-Term Safety of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C)
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ClinicalTrials.gov Identifier: NCT00607971 |
Recruitment Status :
Terminated
(Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.)
First Posted : February 6, 2008
Last Update Posted : July 8, 2008
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Condition or disease | Intervention/treatment | Phase |
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Constipation-Predominant Irritable Bowel Syndrome | Drug: Renzapride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 939 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-Term Safety of Renzapride 4 mg Once Daily in Women With Constipation-Predominant Irritable Bowel Syndrome (IBS-C) |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
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Experimental: 1
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
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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
Other Names:
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- Adverse events [ Time Frame: One year ]
- Vital signs, routine clinical laboratory data, 12-lead ECG [ Time Frame: One year ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL
Exclusion Criteria:
- Subjects who are pregnant or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607971

Principal Investigator: | Anthony Lembo, MD | Beth Israel Deaconess Medical Center, Boston |
Responsible Party: | Research & Development Director, Alizyme Therapeutics Ltd |
ClinicalTrials.gov Identifier: | NCT00607971 |
Other Study ID Numbers: |
ATL1251/052/CL |
First Posted: | February 6, 2008 Key Record Dates |
Last Update Posted: | July 8, 2008 |
Last Verified: | July 2008 |
Constipation predominant irritable bowel syndrome |
Irritable Bowel Syndrome Syndrome Constipation Disease Pathologic Processes Signs and Symptoms, Digestive Colonic Diseases, Functional Colonic Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Renzapride Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |