Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

This study has been completed.
Information provided by:
Salix Pharmaceuticals 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 Salix Pharmaceuticals:

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
Salix Pharmaceuticals
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided by Salix Pharmaceuticals

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 Salix Pharmaceuticals:

Additional relevant MeSH terms:
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 March 26, 2015