NCT01324570

Safety, Pharmacokinetics (PK), and Efficacy of Buprenorphine Transdermal System (BTDS) in Children

An Open-label, Multicenter Study of the Safety, Pharmacokinetics, and Efficacy of Buprenorphine Transdermal System (BTDS) in Children From 7 to 16 Years of Age, Inclusive, Who Require Continuous Opioid Analgesia for Moderate to Severe Pain

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: All
• Age: 7 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Buprenorphine transdermal system	Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.

Timeline

• Start date: 2011-07-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2011-03-29
• Last updated: 2017-07-06
• Results posted: 2017-07-06

Locations

22 sites across 1 country: United States