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 4 weeks prior to surgery
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2002
Estimated Enrollment :
451 Patients enrolled
Trial Details
Trial ID
NCT00388258
Start Date
March 1 2001
End Date
December 1 2002
Last Update
August 22 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Various
Exton, Pennsylvania, United States, 19341