Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced it has closed patient enrollment in its plecanatide phase 2b clinical trial in irritable bowel syndrome with constipation (IBS-C).
The clinical trial is being conducted at approximately 70 sites in the United States and includes four doses of plecanatide (0.3mg, 1.0mg, 3.0mg, 9.0mg) plus a placebo arm, taken once daily over a period of 12 weeks. The primary endpoint is change from baseline in the mean number of complete spontaneous bowel movement (CSBM) over the 12 week treatment period. The first patient was dosed on December 27, 2012 and Synergy anticipates reporting topline data in the beginning of the second quarter of 2014.
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