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

Phase 3

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Renzapride

• Registration Number: NCT00268879
• Lead Sponsor: Alizyme

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-13
• Last Update Posted: 2008-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1821

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Renzapride	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.
3	Renzapride	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.
1	Renzapride	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.

Primary Outcome Measures

Name	Time	Method
Number of months a patient is a Responder for overall relief of IBS symptoms	12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention	12 weeks

Trial Locations

Locations (1)

Alizyme; 🇬🇧 Cambridge, United Kingdom