Synergy Pharmaceuticals Initiates Phase 2 Study of SP-333 in Patients With Opioid-Induced Constipation
10/31/2013 12:08:41 PM
NEW YORK--(BUSINESS WIRE)--Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) today announced the start of a phase 2 clinical trial to evaluate the safety and efficacy of SP-333, its second-generation GC-C agonist and once-daily oral treatment, in adult patients with opioid-induced constipation (OIC). The multi-center, randomized, double-blind clinical trial will compare a 4-week, dose-ranging regimen of SP-333 (1.0, 3.0 and 6.0mg) against placebo in adult patients taking opioid analgesics for chronic, non-cancer pain for at least three months. The study plans to enroll 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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