Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus - Full Text View

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:

Drug Information available for: Methylnaltrexone

U.S. FDA Resources

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

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):

Yu CS, Chun HK, Stambler N, Carpenito J, Schulman S, Tzanis E, Randazzo B. Safety and efficacy of methylnaltrexone in shortening the duration of postoperative ileus following segmental colectomy: results of two randomized, placebo-controlled phase 3 trials. Dis Colon Rectum. 2011 May;54(5):570-8.

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
Gastrointestinal Diseases
Digestive System Diseases
Methylnaltrexone
Naltrexone
Narcotic Antagonists

Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013