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

This study has been terminated.
(Terminated due to insufficient efficacy over placebo in Study ATL1251/038/CL.)
Sponsor:
Information provided by:
Alizyme
ClinicalTrials.gov Identifier:
NCT00607971
First received: January 23, 2008
Last updated: July 4, 2008
Last verified: July 2008
  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).


Condition Intervention Phase
Constipation-Predominant Irritable Bowel Syndrome
Drug: Renzapride
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Alizyme:

Primary Outcome Measures:
  • Adverse events [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs, routine clinical laboratory data, 12-lead ECG [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 939
Study Start Date: April 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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:
  • ATL-1251
  • BRL 24924

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • completed 12 weeks treatment in the preceding pivotal study ATL1251/038/CL

Exclusion Criteria:

  • Subjects who are pregnant or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607971

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United States, Alabama
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Huntsville, Alabama, United States, 35801
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Chandler, Arizona, United States, 85225
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Sponsors and Collaborators
Alizyme
Investigators
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center, Boston
  More Information

No publications provided

Responsible Party: Research & Development Director, Alizyme Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT00607971     History of Changes
Other Study ID Numbers: ATL1251/052/CL
Study First Received: January 23, 2008
Last Updated: July 4, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Alizyme:
Constipation predominant irritable bowel syndrome

Additional relevant MeSH terms:
Constipation
Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Renzapride
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014