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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
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Resource links provided by NLM:

Drug Information available for: Alvimopan
U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals:

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
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
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
Cubist Pharmaceuticals
GlaxoSmithKline
Investigators
Study Director: Adolor Corporation Cubist Pharmaceuticals
  More Information

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00388401     History of Changes
Other Study ID Numbers: 14CL313
Study First Received: October 13, 2006
Last Updated: October 27, 2008
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cubist Pharmaceuticals:
Postoperative Ileus

Additional relevant MeSH terms:
Intestinal Diseases
Ileus
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Obstruction
Analgesics, Opioid
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 21, 2013