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news.Norgine and Tranzyme have completed patient enrollment in ULISES 007, first of two Phase 3 trials of ulimorelin to accelerate gastrointestinal (GI) recovery in patients undergoing partial bowel resection.
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The Phase 3 program includes two randomized, double-blind, placebo-controlled studies, ULISES 007 and ULISES 008.
The objective is to evaluate the efficacy and safety of daily 160 and 480µg/kg doses versus a placebo arm.
The primary endpoint of time to GI recovery defined as the time to the latest of first bowel movement and tolerance of solid food.
Tranzyme Pharma president and CEO Vipin Garg said that they expect to report top-line results from this trial in the spring of 2012.