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

  Hide Study Locations
Locations
United States, Alabama
Mobile, Alabama, United States, 36617
United States, Arkansas
Fort Smith, Arkansas, United States, 72901
United States, California
Chula Vista, California, United States, 92114
Colton, California, United States, 92324
Los Angeles, California, United States, 90033
Oceanside, California, United States, 92056
Palo Alto, California, United States, 94304
San Jose, California, United States, 95124
Torrance, California, United States, 90509
United States, Colorado
Denver, Colorado, United States, 80262
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Bay Minette, Florida, United States, 36507
Jacksonville, Florida, United States, 322224
Melbourne, Florida, United States, 32901
Naples, Florida, United States, 34119
St. Petersburg, Florida, United States, 33701
Vero Beach, Florida, United States, 32960
Weston, Florida, United States, 33331
United States, Georgia
Atlanta, Georgia, United States, 30342
Atlanta, Georgia, United States, 30303
Marietta, Georgia, United States, 30060
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612
Naperville, Illinois, United States, 60540
Park Ridge, Illinois, United States, 60068
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Boston, Massachusetts, United States, 02135
United States, Minnesota
St. Paul, Minnesota, United States, 55114
St. Paul, Minnesota, United States, 55104
United States, New York
Albany, New York, United States, 12208
Kingston, New York, United States, 12401
New York, New York, United States, 10029
New York, New York, United States, 10016
Syracuse, New York, United States, 13210
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland, Ohio, United States, 44109
Columbus, Ohio, United States, 43210
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Bend, Oregon, United States, 97701
Portland, Oregon, United States, 97239
United States, Pennsylvania
Danville, Pennsylvania, United States, 17822
Hershey, Pennsylvania, United States, 17033
Philadelphia, Pennsylvania, United States, 19104
Pittsburgh, Pennsylvania, United States, 15213
Wilkes-Barre, Pennsylvania, United States, 18711
United States, Rhode Island
Pawtucket, Rhode Island, United States, 02860
Providence, Rhode Island, United States, 02903
United States, Tennessee
Memphis, Tennessee, United States, 38103
Nashville, Tennessee, United States, 37232
United States, Texas
Fort Worth, Texas, United States, 76104
Fort Worth, Texas, United States, 76107
San Antonio, Texas, United States, 78212
United States, Virginia
Charlottesville, Virginia, United States, 22908
Norfolk, Virginia, United States, 23507
Winchester, Virginia, United States, 22601
Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Elizabeth Vale, South Australia, Australia, 5112
Woodville South, South Australia, Australia, 5011
Former Serbia and Montenegro
Beograd, Former Serbia and Montenegro, 11000
Germany
Berlin, Germany, 13353
Halle, Germany, 06097
Heidelberg, Germany, 69120
Munchen, Germany, 80336
Hungary
Budapest, Hungary, 1125
Gyor, Hungary, 9024
Pecs, Hungary, 7624
Szekesfehervar, Hungary, 8000
Italy
Osio Sotto, Zingonia, Italy, 24040
Bologna, Italy, 40138
Ferrara, Italy, 44100
Genova, Italy, 16132
Monza, Italy, 20052
Padova, Italy, 35128
Roma, Italy, 00168
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Poland
Katowice, Poland, 40-752
Krakow, Poland, 31-202
Lodz, Poland, 91-425
Poznan, Poland, 60-355
Romania
Bucharest, Romania, 014461
Bucharest, Romania, 042122
Bucharest, Romania, 020475
Bucharest, Romania, 050098
South Africa
Pretoria, Gauteng, South Africa, 0181
Pretoria, Gauteng, South Africa, 0084
Pietermaritzburg, Kwa-Zulu Natal, South Africa, 3201
Cape Town, Western Cape, South Africa, 7580
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
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 October 16, 2014