At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 155 enrolled
Drug / intervention
Oxycodone HCl controlled-release tabletsdrug
Likely dose
Oxycodone HCl controlled-release tablets 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Multicenter Study of the Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Opioid Experienced Children From Ages 6 to 16 Years Old, Inclusive, With Moderate to Severe Malignant and/or Nonmalignant Pain Requiring Opioid Analgesics
In Brief
A Phase 3 clinical trial evaluating Oxycodone HCl controlled-release tablets for Pain. Completed, enrolled 155 participants across 47 sites in 8 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesGreece, Hungary, Israel, New Zealand, Romania, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartNov 2010
Primary CompletionJul 2014
TodayJul 2026
First PostedSep 1, 2010
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 15.8 years ago
Interventions
Oxycodone HCl controlled-release tabletsdrug
Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.