The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy who completed the 4 -week treatment period in OTR3001.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Children's Hospital of Alabama
Birmingham, Alabama, United States
Bayview Research Group, LLC
Paramount, California, United States
The Number of Participants With Adverse Events as a Measure of Safety.
Safety assessments included adverse events (AEs), vital sign measurements, clinical laboratory test results, and somnolence (University of Michigan Sedation Scale \[UMSS\]). Safety variables were summarized descriptively within age group for the extension safety population.
Time frame: Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
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Children's Hospital Colorado
Aurora, Colorado, United States
Jackson Memorial Hospital
Miami, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Mercy Clinic Children's Cancer and Hematology Center
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New York University Langone Medical Center
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...and 4 more locations