Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
- Registration Number
- NCT01369615
- Lead Sponsor
- Purdue Pharma LP
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oxycodone HCl controlled-release Oxycodone hydrochloride controlled-release tablets Oxycodone hydrochloride controlled-release tablets
- Primary Outcome Measures
Name Time Method 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). 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
Bayview Research Group, LLC
🇺🇸Paramount, California, 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
🇮🇱Petach Tikva, Israel
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States