At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 41 enrolled
Drug / intervention
Buprenorphine transdermal systemdrug
Likely dose
Buprenorphine transdermal system 2.5 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Buprenorphine transdermal system for Pain. Completed, enrolled 41 participants across 22 sites.
Detailed Summary
The purpose of this study is to characterize the safety, PK, and efficacy of BTDS in patients of ages 7 to 16 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartJul 2011
Primary CompletionMay 2016
TodayJul 2026
First PostedMar 29, 2011
Enrollment StartJul 1, 2011
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.3 years ago
Interventions
Buprenorphine transdermal systemdrug
Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.