Study Evaluating IV Methylnaltrexone for the Treatment of Post Operative Ileus

NCT00387309 | Completed Phase 3

• 1 other identifier: 3200L2-300
• Study Type: interventional
• Target: 495
• Locations: 10 countries
• Sites: 92

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.

Conditions

Post Operative Bowel Dysfunction

Keywords

Bowel

Outcome Measures

Primary Outcomes (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.

Interventions

Methylnaltrexone (MOA-728) DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (92)

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Mobile, Alabama, 36617, United States

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Fort Smith, Arkansas, 72901, United States

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Chula Vista, California, 92114, United States

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Colton, California, 92324, United States

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Los Angeles, California, 90033, United States

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Oceanside, California, 92056, United States

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Palo Alto, California, 94304, United States

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San Jose, California, 95124, United States

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Torrance, California, 90509, United States

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Denver, Colorado, 80262, United States

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Washington D.C., District of Columbia, 20007, United States

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Bay Minette, Florida, 36507, United States

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Jacksonville, Florida, 322224, United States

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Melbourne, Florida, 32901, United States

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Naples, Florida, 34119, United States

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St. Petersburg, Florida, 33701, United States

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Vero Beach, Florida, 32960, United States

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Weston, Florida, 33331, United States

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Atlanta, Georgia, 30303, United States

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Atlanta, Georgia, 30342, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60611, United States

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Chicago, Illinois, 60612, United States

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Naperville, Illinois, 60540, United States

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Park Ridge, Illinois, 60068, United States

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Kansas City, Kansas, 66160, United States

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Lexington, Kentucky, 40536, United States

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New Orleans, Louisiana, 70121, United States

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Hagerstown, Maryland, 21740, United States

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Boston, Massachusetts, 02135, United States

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Saint Paul, Minnesota, 55104, United States

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Saint Paul, Minnesota, 55114, United States

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Albany, New York, 12208, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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New York, New York, 10029, United States

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Syracuse, New York, 13210, United States

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Chapel Hill, North Carolina, 27599, United States

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Cleveland, Ohio, 44109, United States

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Columbus, Ohio, 43210, United States

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Zanesville, Ohio, 43701, United States

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Oklahoma City, Oklahoma, 73104, United States

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Bend, Oregon, 97701, United States

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Portland, Oregon, 97239, United States

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Danville, Pennsylvania, 17822, United States

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Hershey, Pennsylvania, 17033, United States

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Philadelphia, Pennsylvania, 19104, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Pawtucket, Rhode Island, 02860, United States

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Providence, Rhode Island, 02903, United States

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Memphis, Tennessee, 38103, United States

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Nashville, Tennessee, 37232, United States

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Fort Worth, Texas, 76104, United States

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Fort Worth, Texas, 76107, United States

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San Antonio, Texas, 78212, United States

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Charlottesville, Virginia, 22908, United States

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Norfolk, Virginia, 23507, United States

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Winchester, Virginia, 22601, United States

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Camperdown, New South Wales, 2050, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Woodville South, South Australia, 5011, Australia

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Berlin, 13353, Germany

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Halle, 06097, Germany

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Heidelberg, 69120, Germany

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München, 80336, Germany

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Budapest, 1125, Hungary

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Győr, 9024, Hungary

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Pécs, 7624, Hungary

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Székesfehérvár, 8000, Hungary

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Osio Sotto, Zingonia, 24040, Italy

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Bologna, 40138, Italy

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Ferrara, 44100, Italy

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Genova, 16132, Italy

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Monza, 20052, Italy

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Padua, 35128, Italy

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Roma, 00168, Italy

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Katowice, 40-752, Poland

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Krakow, 31-202, Poland

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Lodz, 91-425, Poland

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Poznan, 60-355, Poland

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Bucharest, 014461, Romania

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Bucharest, 020475, Romania

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Bucharest, 042122, Romania

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Bucharest, 050098, Romania

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Beograd, 11000, Serbia and Montenegro

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Pretoria, Gauteng, 0084, South Africa

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Pretoria, Gauteng, 0181, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3201, South Africa

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Cape Town, Western Cape, 7580, South Africa

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Related Publications (1)

• 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.

  PMID: 21471758 DERIVED

MeSH Terms

Interventions

methylnaltrexone

Study Officials

• Jeff Cohn

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 13, 2006
• Study Start: December 1, 2006
• Study Completion: November 1, 2007
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

PL (4); HU (4); RO (4); SE (1); IT (7); KR (2); DE (4); AU (3); ZA (4); US (59)