Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001

Completed · Phase 3

Conditions studied: Pain

In brief

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.

Key facts

Study ID: NCT01369615
Run by: Purdue Pharma LP
People needed: 23
Starts: 2011-10-01
Expected to finish: 2014-05-01
Last updated by the study team: 2015-09-09

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

Where it is running

Children's Hospital of Alabama — Birmingham, Alabama, United States
Bayview Research Group, LLC — Paramount, California, United States
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 — St Louis, Missouri, United States
New York University Langone Medical Center — New York, New York, United States
Stony Brook University Hospital — Stony Brook, New York, United States
Presbyterian Blume Pediatric Hematology & Oncology Clinic — Charlotte, North Carolina, United States
Akron Children's Hospital — Akron, Ohio, United States
The Children's Hospital at Oklahoma University Medical Center — Oklahoma City, Oklahoma, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
Children's Medical Center of Dallas — Dallas, Texas, United States
Schneider Children Medical Center of Israel — Petah Tikva, Israel

Full record on ClinicalTrials.gov

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