Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus
Study Details
Study Description
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, 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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 duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection of hysterectomy.
Study Design
Outcome Measures
Primary Outcome Measures
- acceleration of gastrointestinal recovery []
Secondary Outcome Measures
- time until ready for discharged based upon recovery of GI function []
- severity of GI symptoms []
- pain []
- opioid consumption []
- time to tolerate solid food []
- need for reinsertion of nasogastric tube []
- time until discharge order is written []
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Various | Exton | Pennsylvania | United States | 19341 |
Sponsors and Collaborators
- Cubist Pharmaceuticals LLC
- GlaxoSmithKline
Investigators
- Study Director: Adolor Corporation, Cubist Pharmaceuticals LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3753-015
- 14CL302