Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects



Status:Archived
Conditions:Chronic Pain, Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2008
End Date:December 2010

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An Open-Label Safety and Tolerability Study of Immediate-Release and Extended-Release Oxymorphone in Opioid-Tolerant Pediatric Subjects With Chronic Pain.


Patients will convert from current opioid to Oxymorphone ER and undergo titration. During
the Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s)
every 12 hours. Dosing adjustments will be based on the review of the subject's pain
scores. Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain
medication (as needed). Titration Period will end when the fixed dose of study medication
is tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the
open-label 3-month maintenance period on the fixed dose of study medication established
during the Titration Period.



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Ann Arbor, Michigan 48106
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282 Washington St
Hartford, Connecticut 06106
(860) 545-9000
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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4243 Sunbeam Road
Jacksonville, Florida 32257
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4575 North Rd
Miami, Florida 34104
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Houston, TX
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Indianapolis, Indiana 46250
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Indianapolis, IN
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Marietta, Georgia 30060
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford university Hospital and Clinics Throughout our history, we have pioneered medical advances that save...
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Winston-Salem, North Carolina 27103
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