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 and 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
- NCT00388479
- Run by
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 666
- Starts
- 2001-12-01
- Expected to finish
- 2003-11-01
- Last updated by the study team
- 2015-07-20
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 with 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 has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery Subject has been on chronic (>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery.
Where it is running
- Various — Exton, Pennsylvania, United States
Full record on ClinicalTrials.gov
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