Trial Information

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing Laparoscopic/Hand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer, Polypectomy or Diverticulitis

This randomized, double-blind, placebo-controlled study was designed to evaluate the
efficacy and tolerability of two dose levels of asimadoline on the duration of
post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon
resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive
either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen
subjects were planned, and in the event that a subject was converted from a laparoscopic
surgery to an open surgery (laparotomy), that subject would be discontinued from the trial
and followed for safety only. The protocol allowed subjects converted to open procedures to
be replaced. The first dose was administered approximately 90 minutes pre-operatively, and
subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with
study drug only while in the hospital. After discharge, they were followed for an additional
28 days. Total study duration for each patient was approximately 5 to 6 weeks.