Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

This study has been completed.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: October 11, 2006
Last updated: July 22, 2011
Last verified: July 2011
Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the investigational MOA-728 regimen than with a placebo regimen.

Condition Intervention Phase
Post Operative Bowel Dysfunction
Drug: Methylnaltrexone (MOA-728)
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, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Intravenous Methylnaltrexone (MOA-728) for the Treatment of Post Operative Ileus.

Resource links provided by NLM:

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Primary Objective: In subjects who have undergone segmental colectomy, the time between the end of surgery and first bowel movement is significantly shorter with the MOA-728 regimen than with a placebo regimen.

Estimated Enrollment: 495
Study Start Date: December 2006
Study Completion Date: November 2007

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


  • Must be scheduled for a segmental colectomy via open laparotomy with general anesthesia
  • Subjects with history of inflammatory bowel disease are eligible as long as the disease is not currently active and all other criteria are met
  • Subjects must meet the American Society of Anesthesiologists physical status I, II or III


  • Subjects who are scheduled for laparoscopic surgery for the segmental colectomy
  • Subjects with a recent history (<1 year prior to randomization) of abdominal radiation therapy; Subjects with a history of small bowel obstruction, known or suspected bowel adhesions (other than minor, clinically nonsignificant adhesions)
  • Subjects undergoing operations resulting in gastrointestinal ostomies, or who require use of post operative nonsteroidal anti-inflammatory drugs (NSAIDs)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00387309

  Show 92 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

No publications provided by Valeant Pharmaceuticals International, Inc.

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00387309     History of Changes
Other Study ID Numbers: 3200L2-300
Study First Received: October 11, 2006
Last Updated: July 22, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency
China: Ministry of Health
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
European Union: European Medicines Agency
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Mexico: National Institute of Public Health, Health Secretariat
New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees
Poland: Ministry of Health
Romania: State Institute for Drug Control
South Africa: Medicines Control Council
South Africa: National Health Research Ethics Council
Taiwan: Department of Health
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Valeant Pharmaceuticals International, Inc.:

Additional relevant MeSH terms:
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 27, 2015