Conditions: Pain
Keywords: Malignant pain Nonmalignant pain Pediatric Opioid Moderate to severe malignant or nonmalignant pain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 155
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Oxycodone hydrochloride (HCl) controlled-release (CR)

Interventions: intervention 1: Oxycodone HCl controlled-release tablets
Intervention descriptions: intervention 1: Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.

Protocol document: