-- The NEW Official Alizyme Thread! --

Before Christmas (Post 20083) I mentioned that I had been told AZM had commenced recruitment into PIII Renzapride c-IBS, but I was unable to provide verification. However, I now have definitive evidence they commenced recruitment into PIII Renzapride c-IBS (at several centres throughout the US) earlier this month. Significantly, it looks like they are only recruiting females (refer Eligibility Criteria) in comparison with the PII trial, which recruited males and females. Females are easier to treat than males and hence the PIII results should be better than the combined male+female PII results, placing it well ahead of Zelnorm for female results imo (Zelnorm is only labelled for females). Details as follows:



This study is currently recruiting patients.
Verified by Alizyme December 2005

Sponsored by: 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
Constipation-Predominant Irritable Bowel Syndrome
Drug: Renzapride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, 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)

Primary Outcomes: Number of months a patient is a Responder for overall relief of IBS symptoms
Secondary Outcomes: Number of months a patient is a Responder for relief of abdominal pain/discomfort, bowel problems, and bloating/abdominal distention
Expected Total Enrollment: 1700
Study start: December 2005

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.

Ages Eligible for Study: 18 Years - 65 Years,

Genders Eligible for Study: Female

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.