NCT01160614

Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Analgesia

Interventions

Type	Name	Description
DRUG	Oxycodone hydrochloride controlled-release (ORF) tablets	Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-07-12
• Last updated: 2012-10-15
• Results posted: 2012-08-21

Locations

17 sites across 4 countries: United States, Australia, Finland, New Zealand