At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 30 enrolled
Drug / intervention
Oxycodone hydrochloride controlled-release (ORF) tabletsdrug
Likely dose
Oxycodone hydrochloride controlled-release (ORF) tablets 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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An Open-label Study to Characterize the Pharmacokinetics and Safety of Oxycodone Hydrochloride q12h Controlled-Release (ORF) Tablets in Pediatric Patients Aged 6 to 16 Years Inclusive, Who Require Opioid Analgesia
In Brief
A Phase 1 clinical trial evaluating Oxycodone hydrochloride controlled-release (ORF) tablets for Opioid Analgesia. Completed, enrolled 30 participants across 17 sites in 4 countries.
Detailed Summary
The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF tablets in pediatric patients aged 6 to 16 years, inclusive.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid Analgesia
CountriesAustralia, Finland, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedJul 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedJul 12, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.0 years ago
Interventions
Oxycodone hydrochloride controlled-release (ORF) tabletsdrug
Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours