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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00388258
First Posted: October 16, 2006
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


Further study details as provided by Cubist Pharmaceuticals LLC:

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

Estimated Enrollment: 451
Actual Study Start Date: March 1, 2001
Study Completion Date: December 1, 2002
Primary Completion Date: December 1, 2002 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 4 weeks prior to surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388258


Locations
United States, Pennsylvania
Various
Exton, Pennsylvania, United States, 19341
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Investigators
Study Director: Adolor Corporation Cubist Pharmaceuticals LLC
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00388258     History of Changes
Other Study ID Numbers: 3753-015
14CL302 ( Other Identifier: Cubist Study Number )
First Submitted: October 13, 2006
First Posted: October 16, 2006
Last Update Posted: August 22, 2017
Last Verified: August 2017

Keywords provided by Cubist Pharmaceuticals LLC:
Postoperative ileus

Additional relevant MeSH terms:
Ileus
Intestinal Diseases
Intestinal Obstruction
Gastrointestinal Diseases
Digestive System Diseases
Alvimopan
Gastrointestinal Agents