An Open-label, Extension Study to Assess the Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children Who Completed the OTR3001 Study
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The number of participants with adverse events as a measure of safety.
Up to 6 months (during the study) and 7-10 days poststudy (safety follow-up assessment).
Yes
United States: Food and Drug Administration
OTR3002
NCT01369615
October 2011
March 2014
Name | Location |
---|---|
Primary Children's Medical Center | Salt Lake City, Utah 84113-1100 |
Akron Children's Hospital | Akron, Ohio 44308-1062 |
Children's Medical Center of Dallas | Dallas, Texas 75235 |
Children's Hospital of Alabama | Birmingham, Alabama 35233 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Stony Brook University Hospital | Stony Brook, New York 11794-8174 |
New York University Langone Medical Center | New York, New York 10016 |
Lynn Health Sciences Institute | Oklahoma City, Oklahoma 73112 |
Lynn Institute of the Rockies | Colorado Springs, Colorado 80909 |
Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville, Tennessee 37232 |
Children's Hospital Colorado | Aurora, Colorado 80045 |
Bayview Research Group, LLC | Paramount, California 90723 |
Mercy Clinic Children's Cancer and Hematology Center | St. Louis, Missouri 63141 |
Presbyterian Blume Pediatric Hematology & Oncology Clinic | Charlotte, North Carolina 28204 |
The Children's Hospital at Oklahoma University Medical Center | Oklahoma City, Oklahoma 73104 |