Conditions: Pain
Keywords: Pain Opioid Analgesia Moderate to severe pain
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.

Detailed description:
A study of safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years, inclusive, who require continuous opioid analgesia for moderate to severe pain.

Arms:
arm 1: Buprenorphine transdermal system

Interventions: intervention 1: Buprenorphine transdermal system
Intervention descriptions: intervention 1: Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.

Protocol document: