Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Low Back Pain
NCT ID: NCT01431742
Last Updated: 2012-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BEMA Buprenorphine
buprenorphine buccal soluble film
BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Interventions
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BEMA Buprenorphine
buccal soluble film; applied to the buccal mucosa twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BioDelivery Sciences International
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew Finn, PharmD
Role: STUDY_CHAIR
BioDelivery Sciences International
Locations
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Marietta, Georgia, United States
Countries
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Other Identifiers
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BUP-306
Identifier Type: -
Identifier Source: org_study_id
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