Adolor has completed enrollment in a Phase III clinical trial, comprising approximately 660 patients, that is evaluating Entereg (alvimopan) for the management of postoperative ileus by acceleration of the time to recovery of gastrointestinal (GI) function following bowel resection surgery.
The study is a double-blind, placebo-controlled pivotal trial. Under the protocol, patients were randomized to receive either 12 mg of Entereg or placebo twice daily, with an initial dose given 30 to 90 minutes prior to surgery. In previous Phase III studies, the initial dose was to be administered at least 120 minutes prior to surgery. The primary endpoint is time to recovery of GI function.