Investigation of the Safety and Efficacy of Renzapride in Constipation Predominant Irritable Bowel Syndrome (IBS) - Full Text View

Sponsor:	Alizyme
Information provided by:	Alizyme
ClinicalTrials.gov Identifier:	NCT00268879

Purpose

The purpose of the study is to investigate whether renzapride will help alleviate the symptoms associated with constipation predominant irritable bowel syndrome in female patients.

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Renzapride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)

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:

Number of months a patient is a Responder for overall relief of IBS symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	1821
Study Start Date:	December 2005
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.	Drug: Renzapride Placebo Renzapride 4 mg QD Renzapride 2 mg BID
2: Experimental Renzapride 4 mg QD. Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.	Drug: Renzapride Placebo Renzapride 4 mg QD Renzapride 2 mg BID
3: Experimental Renzapride 2 mg BID: Two capsules are taken by mouth each morning and each evening from the day of the randomization visit until the scheduled visit at the end of Week 12.	Drug: Renzapride Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Detailed Description:

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent symptoms of abdominal pain/discomfort accompanied by disturbed bowel function.

In this study female patients with constipation predominant IBS will receive one of two dosing regimens of renzapride or placebo for 12 weeks. Patients will record the severity of their symptoms throughout the study. The results will be analysed to see if those patients who received renzapride had greater relief of their symptoms than did the patients who received placebo.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females with constipation predominant IBS as defined by the Rome II criteria
Colonoscopy or sigmoidoscopy in previous 5 years showed no significant disease

Exclusion Criteria:

Patients who have diarrhoea predominant or alternating symptom IBS
Other gastrointestinal diseases that affect bowel transit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268879

Locations

United Kingdom
Alizyme
Cambridge, United Kingdom

Sponsors and Collaborators

Alizyme

Investigators

Principal Investigator:

Anthony Lembo

Beth Israel Deaconess Medical Centre, Boston

More Information

No publications provided

Responsible Party:	Alizyme ( Research and Development Director )
Study ID Numbers:	ATL1251/038/CL
Study First Received:	December 22, 2005
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00268879 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alizyme:

Irritable bowel syndrome
Constipation-predominant irritable bowel syndrome

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 November 30, 2009