-- The NEW Official Alizyme Thread! --

Looks like they sneaked this in just before xmas !!!

This is market sensitive news surely -- commencement of renzapride trials wthout a partner !!!




More Information

Study ID Numbers: ATL1251/038/CL

********* Last Updated: December 22, 2005 **********

********Record first received: December 22, 2005 ********

ClinicalTrials.gov Identifier: NCT00268879
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-12-30


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


MedlinePlus consumer health information


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)

Further Study Details:
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