Low Back Pain, Pain
Conditions
Keywords
buccal soluble film, Pain, Back Pain, Low Back Pain, Buprenorphine, Analgesics, Opioid, Analgesics
Brief summary
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic low back pain. BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.
Interventions
buccal soluble film; applied to the buccal mucosa twice daily
Sponsors
BioDelivery Sciences International
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or non-pregnant and non-nursing female aged 18 or older * History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported during screening following discontinuation of current pain medication (opioids and NSAIDs) AND currently taking ≥10 mg oral morphine equivalent/day for ≥2 weeks * Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures * Female subjects of childbearing potential must be using a recognized effective method of birth control * Written informed consent obtained prior to any procedure being performed
Exclusion criteria
* Cancer related pain * Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis * Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit * History of severe emesis with opioids * Clinically significant sleep apnea in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in pain intensity | Baseline up to approximately Week 52 | The average of the visit pain scores for Baseline up to approximately Week 52 |
Countries
United States
Outcome results
None listed