Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
WithdrawnPhase 3NCT01431742
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain
- Conditions
- Interventions
- Drug: BEMA Buprenorphine
- Sponsor
- BioDelivery Sciences International
- Start date
- 2012-07
- Primary completion
- 2013-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01431742