At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 334 enrolled
Drug / intervention
Buprenorphine +1 moredrug
Likely dose
Not stated in 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.
A 12-Week, Placebo Controlled, Double Blind, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Buprenorphine HCl Buccal Film in Subjects With Moderate to Severe Chronic Low Back Pain
In Brief
A Phase 3 clinical trial evaluating Buprenorphine and Placebo for Pain and Low Back Pain. Completed, enrolled 334 participants across 24 sites.
Detailed Summary
The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Low Back Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2010
First PostedDec 2010
Primary CompletionJul 2011
TodayJul 2026
First PostedDec 8, 2010
Enrollment StartNov 1, 2010
Primary CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.6 years ago
Interventions
Buprenorphinedrug
buccal soluble film; applied to the buccal mucosa twice daily
Placebodrug
buccal soluble film; applied to the buccal mucosa twice daily