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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Trial Summary
Trial Overview
Inclusion Criteria

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.



We found this trial at
13
sites
Children's Medical Center of Dallas
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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Dallas, TX
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Connecticut Children's Medical Center
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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Hartford, CT
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Florida Institute of Medical Research
4243 Sunbeam Road
Jacksonville, Florida 32257
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Jacksonville, FL
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Tukoi Clinical Research
4575 North Rd
Miami, Florida 34104
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Miami, FL
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St. Joseph's Hospital
Ann Arbor, Michigan 48106
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Ann Arbor, MI
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Penn State Milton S. Hershey Medical Center
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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Hershey, PA
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Children's Nutrition Research Center, Baylor College of Medicine
Houston, Texas 77030
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Houston, TX
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Rehabilitation Associates of Indiana
Indianapolis, Indiana 46250
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Indianapolis, IN
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Arkansas Children's Hospital
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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Little Rock, AR
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University of Louisville Hospital
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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Louisville, KY
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Taylor Research LLC
Marietta, Georgia 30060
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Marietta, GA
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Stanford university Hospital and Clinics
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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Stanford, CA
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The Center for Clinical Research
Winston-Salem, North Carolina 27103
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Winston-Salem, NC
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