Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00387309
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : July 26, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Post Operative Bowel Dysfunction Drug: Methylnaltrexone (MOA-728) Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 495 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : December 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00387309

  Hide Study 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, 30303
Atlanta, Georgia, United States, 30342
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, 55104
St. Paul, Minnesota, United States, 55114
United States, New York
Albany, New York, United States, 12208
Kingston, New York, United States, 12401
New York, New York, United States, 10016
New York, New York, United States, 10029
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
Berlin, Germany, 13353
Halle, Germany, 06097
Heidelberg, Germany, 69120
Munchen, Germany, 80336
Budapest, Hungary, 1125
Gyor, Hungary, 9024
Pecs, Hungary, 7624
Szekesfehervar, Hungary, 8000
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, 135-710
Seoul, Korea, Republic of, 138-736
Katowice, Poland, 40-752
Krakow, Poland, 31-202
Lodz, Poland, 91-425
Poznan, Poland, 60-355
Bucharest, Romania, 014461
Bucharest, Romania, 020475
Bucharest, Romania, 042122
Bucharest, Romania, 050098
South Africa
Pretoria, Gauteng, South Africa, 0084
Pretoria, Gauteng, South Africa, 0181
Pietermaritzburg, Kwa-Zulu Natal, South Africa, 3201
Cape Town, Western Cape, South Africa, 7580
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.

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
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:

Additional relevant MeSH terms:
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents