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Completed

NCT Number: NCT00268879

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

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Alizyme

Cambridge, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renzapride

Drug

Placebo Renzapride 4 mg QD Renzapride 2 mg BID

Other names: ATL-1251, BRL-24924

Primary outcomes

  1. Number of months a patient is a Responder for overall relief of IBS symptoms

    Time frame: 12 weeks

Secondary outcomes

  1. Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Alizyme

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 23, 2005
Registry last updated
Feb 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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