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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Constipation-Predominant Irritable Bowel Syndrome Drug: Renzapride Phase 3

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 939 participants
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
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Adverse events [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Vital signs, routine clinical laboratory data, 12-lead ECG [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

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


  Show 126 Study Locations
Sponsors and Collaborators
Alizyme
Investigators
Principal Investigator: Anthony Lembo, MD Beth Israel Deaconess Medical Center, Boston
More Information

Responsible Party: Research & Development Director, Alizyme Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT00607971     History of Changes
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

Keywords provided by Alizyme:
Constipation predominant irritable bowel syndrome

Additional relevant MeSH terms:
Syndrome
Constipation
Irritable Bowel Syndrome
Disease
Pathologic Processes
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
Physiological Effects of Drugs