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

Completed · Phase 3

Conditions studied: Ileus

In brief

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, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Key facts

Study ID

NCT00388258

Run by

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

People needed

451

Starts

2001-03-01

Expected to finish

2002-12-01

Last updated by the study team

2017-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
• Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

You may not qualify if…

• Subject is scheduled for a total colectomy, colostomy, ileostomy
• Subject has complete bowel obstruction
• Subject is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery

Where it is running

• Various — Exton, Pennsylvania, United States

Full record on ClinicalTrials.gov

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