Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids
Completed · Phase 3
Conditions studied: Pain
In brief
The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
Key facts
- Study ID
- NCT01192295
- Run by
- Purdue Pharma LP
- People needed
- 155
- Starts
- 2010-11-01
- Expected to finish
- 2014-07-01
- Last updated by the study team
- 2020-03-23
Who can join
Age: 6 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Alabama — Birmingham, Alabama, United States
- University of South Alabama, Children's and Women's Hospital — Mobile, Alabama, United States
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- Loma Linda University Medical Center — Loma Linda, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- LS Packard Children's Hospital — Palo Alto, California, United States
- Bayview Research Group, LLC — Paramount, California, United States
- Shriners Hospitals for Children Northern California — Sacramento, California, United States
- The Children's Hospital — Aurora, Colorado, United States
- Connecticut Children's Medical Center — Hartford, Connecticut, United States
- Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
- Memorial Regional Hospital — Hollywood, Florida, United States
- Jackson Memorial Hospital/University of Miami — Miami, Florida, United States
- Tampa General Hospital — Tampa, Florida, United States
- Children's Memorial Hospital — Chicago, Illinois, United States
- University of Kentucky — Lexington, Kentucky, United States
- Helen DeVos Children's Hospital — Grand Rapids, Michigan, United States
- St. John's Mercy Medical 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 and Oncology Clinic — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Akron Children's Hospital — Akron, Ohio, United States
- Department of Pediatrics, University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
Full record on ClinicalTrials.gov
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