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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase

Completed

Phase 3

Conditions

Ileus

Treatments

Drug: alvimopan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00205842

14CL314 (Other Identifier)

3753-001

Details and patient eligibility

About

Patients undergoing major abdominal surgery are at highest risk for developing Postoperative Ileus (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.

Full description

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.