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Synergy Pharmaceuticals Initiates Second Phase 3 Clinical Trial Of Plecanatide In Patients With Chronic Idiopathic Constipation


4/28/2014 10:51:16 AM

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NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the start of its second pivotal phase 3 clinical trial to confirm the safety and efficacy of plecanatide, its lead uroguanylin analog and once-daily oral treatment, in adult patients with chronic idiopathic constipation (CIC).

This phase 3 trial is a randomized, double-blind clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients with CIC. The study will be conducted at approximately 180 sites in the United States and will enroll approximately 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.

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