Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus
NCT ID: NCT00387309
Last Updated: 2019-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
495 participants
INTERVENTIONAL
2006-12-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Methylnaltrexone (MOA-728)
Eligibility Criteria
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Inclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Salix Pharmaceuticals
Principal Investigators
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Jeff Cohn
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Mobile, Alabama, United States
Fort Smith, Arkansas, United States
Chula Vista, California, United States
Colton, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Palo Alto, California, United States
San Jose, California, United States
Torrance, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Bay Minette, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Naples, Florida, United States
St. Petersburg, Florida, United States
Vero Beach, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Naperville, Illinois, United States
Park Ridge, Illinois, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Saint Paul, Minnesota, United States
Saint Paul, Minnesota, United States
Albany, New York, United States
Kingston, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Zanesville, Ohio, United States
Oklahoma City, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Danville, Pennsylvania, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
Pawtucket, Rhode Island, United States
Providence, Rhode Island, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Winchester, Virginia, United States
Camperdown, New South Wales, Australia
Elizabeth Vale, South Australia, Australia
Woodville South, South Australia, Australia
Berlin, , Germany
Halle, , Germany
Heidelberg, , Germany
München, , Germany
Budapest, , Hungary
Győr, , Hungary
Pécs, , Hungary
Székesfehérvár, , Hungary
Osio Sotto, Zingonia, Italy
Bologna, , Italy
Ferrara, , Italy
Genova, , Italy
Monza, , Italy
Padua, , Italy
Roma, , Italy
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Bucharest, , Romania
Beograd, , Serbia and Montenegro
Pretoria, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Pietermaritzburg, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Seoul, , South Korea
Seoul, , South Korea
Countries
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References
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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. doi: 10.1007/DCR.0b013e3182092bde.
Other Identifiers
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3200L2-300
Identifier Type: -
Identifier Source: org_study_id
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