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

This study has been completed.

Sponsors and Collaborators: Adolor Corporation
GlaxoSmithKline
Information provided by: Adolor Corporation
ClinicalTrials.gov Identifier: NCT00388401
  Purpose

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 Intervention Phase
Ileus
Drug: Alvimopan
Phase III

MedlinePlus related topics:   Nausea and Vomiting   

ChemIDplus related topics:   Alvimopan    LY246736   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Further study details as provided by Adolor Corporation:

Primary Outcome Measures:
  • acceleration of gastrointestinal recovery

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   510
Study Start Date:   January 2002
Estimated Study Completion Date:   June 2003

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 the prior 2 weeks
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388401

Locations
United States, Pennsylvania
Adolor Corporation    
      Exton, Pennsylvania, United States, 19341

Sponsors and Collaborators
Adolor Corporation
GlaxoSmithKline

Investigators
Study Director:     Adolor Corporation     Adolor Corporation    
  More Information


Adolor Corporation home web page address  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   14CL313
First Received:   October 13, 2006
Last Updated:   October 13, 2006
ClinicalTrials.gov Identifier:   NCT00388401
Health Authority:   United States: Food and Drug Administration;   Canada: Health Canada

Keywords provided by Adolor Corporation:
Postoperative Ileus  

Study placed in the following topic categories:
Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 19, 2008




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