Synergy Pharmaceuticals Completes Patient Enrollment For Its SP-333 Phase 2 Trial In Patients With Opioid-Induced Constipation
7/17/2014 10:56:29 AM
NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced that it has successfully completed patient enrollment for its phase 2 trial of SP-333, Synergy’s next-generation uroguanylin analog, in patients with opioid-induced constipation (OIC).
The multi-center, randomized, double-blind clinical trial is designed to compare a 4-week dose-ranging regimen of once-daily oral SP-333 (1.0 mg, 3.0 mg and 6.0 mg) against placebo in patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study will evaluate approximately 260 patients with OIC who have less than 3 spontaneous bowel movements (SBMs) per week and who experience constipation related symptoms. The primary endpoint of the study is mean change from baseline in the number of SBMs during Week 4 of the Treatment Period.
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