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Patient Enrollment Complete for Phase 3 Study of Alvimopan in Postoperative Ileus
"We are pleased to have accomplished this milestone on schedule, putting us on track to achieve our goal of reporting top-line data by March 2006," said James Barrett, Ph.D., senior vice president, chief scientific officer and president, research of Adolor Corporation. "We continue to target June 2006 to submit the final results from this study as part of our complete response to the FDA."
Study 14CL314 is a double-blind, placebo controlled pivotal clinical trial. Under the protocol, patients were randomized to receive either 12 mg Entereg(R) (alvimopan) or placebo twice daily, with initial dose given 30 to 90 minutes prior to surgery. In Adolor's previous Phase 3 studies, the initial dose was to be administered at least 120 minutes prior to surgery. The primary endpoint for Study 314 is time to recovery of GI function. This is a composite measure of the time to recovery of both upper and lower GI function, as defined by time to tolerability of solid foods, and time to first bowel movement, whichever occurred last.
Adolor submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Entereg(R) in June 2004 and received an approvable letter in July 2005.
Source: Adolor Corporation