A Study Evaluating Intravenous (IV) MOA-728 for the Treatment of Postoperative Ileus (POI) in Participants After Ventral Hernia Repair
NCT ID: NCT00528970
Last Updated: 2019-09-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2007-10-17
2008-02-05
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
QUADRUPLE
Study Groups
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MOA-728 12 mg
Participants will receive methylnaltrexone (MOA-728) 12 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
MOA-728 24 mg
Participants will receive MOA-728 24 mg as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
Placebo
Participants will receive placebo matching to MOA-728 as an IV infusion over approximately 20 minutes for approximately every 6 hours for a total of 4 doses in 24-hour period. The first dose of study drug will be administered within approximately 90 minutes after completion of the surgical procedure (defined as the time when the last skin suture or staple is placed in the participant). Dose administration will be continued for a maximum of 10 days.
Placebo
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
Interventions
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MOA-728
MOA-728 will be administered per the dose and schedule specified in the arm.
Placebo
Placebo matching to MOA-728 will be administered per the schedule specified in the arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for ventral wall hernia repair with general anesthesia.
* Meets the American Society of Anesthesiologists physical status I, II, or III.
Exclusion Criteria
* Women who are pregnant or lactating.
* Calculated creatinine clearance (Cockcroft-Gault glomerular filtration rate \[GFR\] formula) less than or equal to (\</=) 50 milliliters/minute (mL/min).
18 Years
ALL
No
Sponsors
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Progenics Pharmaceuticals, Inc.
INDUSTRY
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lindsey Mathew
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Benton, Arkansas, United States
Colton, California, United States
Laguna Hills, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Orange, California, United States
San Jose, California, United States
Santa Barbara, California, United States
Denver, Colorado, United States
Denver, Colorado, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Peoria, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Springfield, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Flint, Michigan, United States
Jackson, Mississippi, United States
Columbia, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
New Brunswick, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
New York, New York, United States
Stony Brook, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Bend, Oregon, United States
Portland, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Providence, Rhode Island, United States
Sioux Falls, South Dakota, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Norfolk, Virginia, United States
Winchester, Virginia, United States
Bellevue, Washington, United States
Tacoma, Washington, United States
Morgantown, West Virginia, United States
Milwaukee, Wisconsin, United States
Adelaide SA, , Australia
Elizabeth Vale SA, , Australia
Wilrijkstraat 10, Edegem, Belgium
De Pintelaan 185, Gent Belgium, Belgium
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Montreal, Quebec, Canada
Nussbaumstrasse 20, Muenchen, Germany
Augustenburger Platz 1, State of Berlin, Germany
Heidelberg, , Germany
Nyíregyháza, , Hungary
Pécs, , Hungary
Székesfehérvár, , Hungary
Veszprém, , Hungary
Corso Giovecca 203, Ferrara, Italy
Gemelli, Rome, Italy
Padua, Via Giustiniani 2, Italy
Bergamo, , Italy
Jan Toorpstraat 164, Amsterdam, Netherlands
Roosendaal, , Netherlands
Powstancow Wielkopolskich 72, Szczecin, Poland
Bydgoszcz, , Poland
Polnocna 42, Łódź Voivodeship, Poland
Durban Kwa-Zulu, KwaZulu-Natal, South Africa
Somerset West, Western Cape, South Africa
Worcester, Western Cape, South Africa
Moreletapark Pretoria, , South Africa
Pretoria, , South Africa
Pretoria Gauteng, , South Africa
Pretoria Gauteng, , South Africa
Kangnam-Gu
Seoul, , South Korea
Countries
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Other Identifiers
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3200L2-301
Identifier Type: -
Identifier Source: org_study_id
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