Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Postoperative ileus (POI) can be thought of as temporary slowing down or stopping of bowel
function and a slowing down of movement of contents of the intestines. Patients undergoing
major abdominal surgery are at highest risk for developing POI, occurring in nearly all
cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent
abdominal pain; nausea and/or vomiting; variable reduction of bowel sounds; delayed passage
of or inability to pass flatus or stool; and inability to tolerate a solid diet. This study
will test the ability of alvimopan 12 mg given 30 to 90 minutes before the scheduled start
of surgery to hasten the recovery of GI function in patients having partial small or large
bowel resections.

Inclusion Criteria:

- Subject is scheduled for a partial small/large bowel resection with primary
anastomosis; all procedures must be performed completely by open laparotomy.

- Subject is scheduled to receive primary postoperative pain management with
intravenous (i.v.) patient-controlled analgesia (PCA) opioids.

Exclusion Criteria:

- Subject is scheduled for a total colectomy, colostomy, ileostomy, any laparoscopic or
laparoscopically-assisted procedure, or subject has a history of gastrectomy, total
colectomy, short bowel syndrome, or multiple previous abdominal surgeries performed
by open laparotomy.

- Subject has complete bowel obstruction.

- Subject is currently taking opioid analgesics or has taken more than three doses of
opioids (oral or parenteral) within the previous 7 days prior to the day of surgery.