Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
NCT ID: NCT00801398
Last Updated: 2019-02-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2009-02-17
2011-04-18
Brief Summary
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This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Oxymorphone IR
Open-Label, 2 part ascending-dose multicenter study
Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Interventions
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Oxymorphone IR
Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Weigh at least 50 kg
* Postoperative oral opioid analgesia required for at least 24 hours or 48 hours following postoperataive parenteral analgesia
* Are expected to be hospitalized for the duration of the study
Exclusion Criteria
* Life expectancy of \< 4 weeks
* Positive pregnancy test at screening
12 Years
17 Years
ALL
Yes
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Arkansas Children's Hospital
Little Rock, Arkansas, United States
Stanford University School of Medicine
Stanford, California, United States
The Children's Hospital
Aurora, Colorado, United States
Children's Research Institute
Washington D.C., District of Columbia, United States
St. Joseph's Children's Hospital of Tampa
Tampa, Florida, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
Hershey Medical Center
Hershey, Pennsylvania, United States
The Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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EN3203-010
Identifier Type: -
Identifier Source: org_study_id
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