Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by:
Cubist Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00388401
First received: October 13, 2006
Last updated: October 27, 2008
Last verified: October 2008

October 13, 2006
October 27, 2008
January 2002
June 2003   (final data collection date for primary outcome measure)
acceleration of gastrointestinal recovery
Same as current
Complete list of historical versions of study NCT00388401 on ClinicalTrials.gov Archive Site
  • time until ready for discharge 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
Same as current
Not Provided
Not Provided
 
Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Ileus
Drug: Alvimopan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
510
June 2003
June 2003   (final data collection date for primary outcome measure)

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 the prior 2 weeks
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388401
14CL313
No
Not Provided
Cubist Pharmaceuticals
GlaxoSmithKline
Study Director: Adolor Corporation Cubist Pharmaceuticals
Cubist Pharmaceuticals
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP