At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 304 enrolled
Drug / intervention
EN3409drug
Likely dose
EN3409 900 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.
A Phase 3, Open-label, Long-term Study to Evaluate the Safety, Tolerability, and Analgesic Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Pain Requiring Continuous Around-the-Clock Opioid Analgesia for an Extended Period of Time
In Brief
A Phase 3 clinical trial evaluating EN3409 for Low Back Pain and 2 related conditions. Completed, enrolled 304 participants across 57 sites.
Detailed Summary
The purpose of the long-terms study is to evaluate the safety, tolerability, and analgesic efficacy of EN3409 in subjects with moderate to severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Osteoarthritis, Neuropathic Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
First PostedDec 2012
Primary CompletionOct 2014
Study CompletionNov 2014
TodayJul 2026
First PostedDec 24, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2014
Study CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago
Interventions
EN3409drug
Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily