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Synergy Pharmaceuticals Inc Begins Phase IIb Trial Of Plecanatide In Irritable Bowel Syndrome With Constipation

Thursday, 27 Dec 2012 05:00am EST 

Synergy Pharmaceuticals Inc announced that dosing has commenced in a Phase IIb clinical trial of plecanatide to treat patients with constipation-predominant irritable bowel syndrome (IBS-C). This trial is being conducted at 70 sites in the United States and includes 350 patients with IBS-C who will be treated with one of four doses of plecanatide (0.3, 1.0, 3.0, or 9.0 mg) or placebo, taken once daily over a period of 12 weeks. PAREXEL International is the Contract Research Organization for the trial. Patients must meet the Rome III criteria for IBS as demonstrated by a history of recurrent abdominal pain or discomfort covering at least three days/month in the last three months associated with two or more of: improvement with defecation, onset associated with a change in frequency of stool, and 3) onset associated with a change in form (appearance) of stool. Patients must also meet the criteria for the IBS-C subtype, which is further characterized by stool pattern such that = 25% of defecations are hard or lumpy stools and = 25% of defecations are loose or watery stools. 

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12 Sep 2014