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

Irritable Bowel Syndrome Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268879
• Other study ID #: ATL1251/038/CL
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: February 13, 2008
• Start date: December 2005
• Est. completion date: January 2008

Study information

• Verified date: February 2008
• Source: Alizyme
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1821
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Renzapride
Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Locations

Country	Name	City	State
United Kingdom	Alizyme	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Alizyme

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of months a patient is a Responder for overall relief of IBS symptoms		12 weeks	No
Secondary	Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention		12 weeks	No