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Alizyme plc
Agreement reached with U.S. FDA for renzapride phase III trial
August 10th, 2005
Alizyme plc (AZM) has reached agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for the design of a pivotal phase III clinical trial for renzapride in constipation-predominant irritable bowel syndrome (c-IBS) in the U.S. The trial will be a multi-centre, randomized, double-blind, placebo-controlled, parallel group, pivotal, efficacy study. The trial will involve up to 1,700 women with c-IBS being treated over a 12-week period. Patients' response will be determined by each patient, via weekly self-assessments of their IBS symptoms. The primary endpoint will be to evaluate whether daily...
Source: Biotech Week (2005-08-10)
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