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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women With Constipation-Predominant Irritable Bowel Syndrome (c-IBS)

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Renzapride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>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<br>* Placebo Renzapride 4 mg QD Renzapride 2 mg BID<br>* Other names: BRL-24924;|
| Experimental: 2<br>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<br>* Placebo Renzapride 4 mg QD Renzapride 2 mg BID<br>* Other names: BRL-24924;|
| Experimental: 3<br>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<br>* Placebo Renzapride 4 mg QD Renzapride 2 mg BID<br>* Other names: BRL-24924;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of months a patient is a Responder for overall relief of IBS symptoms |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable bowel syndrome, Constipation-predominant irritable bowel syndrome