NCT01192295

Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children With Moderate to Severe Malignant and/ or Nonmalignant Pain Requiring Opioids

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (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 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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Oxycodone HCl controlled-release tablets	Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.

Timeline

• Start date: 2010-11-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-09-01
• Last updated: 2020-03-23
• Results posted: 2015-02-06

Locations

47 sites across 8 countries: United States, Greece, Hungary, Israel, New Zealand, Romania, Spain, United Kingdom