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

Sponsored by:	Alizyme
Information provided by:	Alizyme
ClinicalTrials.gov Identifier:	NCT00607971

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 III

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Constipation

Drug Information available for: Renzapride

U.S. FDA Resources

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
1: Experimental 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

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

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

Show 126 Study Locations

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Anthony Lembo, MD

Beth Israel Deaconess Medical Center, Boston

More Information

No publications provided

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

Keywords provided by Alizyme:

Constipation predominant irritable bowel syndrome

Study placed in the following topic categories:

Renzapride
Signs and Symptoms
Neurotransmitter Agents
Digestive System Diseases
Signs and Symptoms, Digestive
Gastrointestinal Diseases

Colonic Diseases
Irritable Bowel Syndrome
Constipation
Intestinal Diseases
Colonic Diseases, Functional
Serotonin

Additional relevant MeSH terms:

Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Intestinal Diseases
Pharmacologic Actions
Signs and Symptoms

Renzapride
Serotonin Antagonists
Serotonin Agents
Digestive System Diseases
Pathologic Processes
Syndrome
Irritable Bowel Syndrome
Constipation
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on September 03, 2009