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 and ...
Detailed 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 su...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT00205842
Start Date
June 1 2004
End Date
December 1 2005
Last Update
January 11 2016
Active Locations (1)
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1
50 Sites
Exton, Pennsylvania, United States, 19341