At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 752 enrolled
Drug / intervention
Buprenorphine +1 moredrug
Likely dose
Buprenorphine 600 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.
Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia
In Brief
A Phase 3 clinical trial evaluating Buprenorphine and Placebo for Low Back Pain. Completed, enrolled 752 participants across 60 sites.
Detailed Summary
The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 2012
Enrollment StartAug 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedJul 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.0 years ago
Interventions
Buprenorphinedrug
Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
Placebodrug
Matching Placebo Buccal Film twice daily