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Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00387309
First received: October 11, 2006
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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
  Eligibility

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

Inclusion:

  • 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

Exclusion:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387309

  Show 92 Study Locations
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov 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:
Bowel

Additional relevant MeSH terms:
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Methylnaltrexone
Naltrexone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014