NCT01431742
Withdrawn
Phase 3
An Open Label, Longterm Treatment Evaluation of the Safety and Efficacy of BEMA® Buprenorphine in Subjects With Moderate to Severe Chronic Low Back Pain
BioDelivery Sciences International0 sitesJuly 2012
Overview
- Phase
- Phase 3
- Intervention
- BEMA Buprenorphine
- Conditions
- Pain
- Sponsor
- BioDelivery Sciences International
- Primary Endpoint
- Mean change in pain intensity
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
BEMA Buprenorphine
buprenorphine buccal soluble film
Intervention: BEMA Buprenorphine
Outcomes
Primary Outcomes
Mean change in pain intensity
Time Frame: Baseline up to approximately Week 52
The average of the visit pain scores for Baseline up to approximately Week 52
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