Status:
COMPLETED
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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, blo...
Detailed Description
Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable durat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 the prior 2 weeks
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00388401
Start Date
January 1 2002
End Date
June 1 2003
Last Update
July 20 2015
Active Locations (1)
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1
Adolor Corporation
Exton, Pennsylvania, United States, 19341