Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain
NCT ID: NCT01298765
Last Updated: 2018-08-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
302 participants
INTERVENTIONAL
2011-03-31
2012-08-31
Brief Summary
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Detailed Description
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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.
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 pain:
1. Subjects completing study BUP-301 (low back pain) or
2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
* 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_DIRECTOR
BioDelivery Sciences International
Locations
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Birmingham, Alabama, United States
Mobile, Alabama, United States
Phoenix, Arizona, United States
Arcadia, California, United States
Fresno, California, United States
La Jolla, California, United States
Long Beach, California, United States
Westminster, Colorado, United States
DeLand, Florida, United States
Jupiter, Florida, United States
Plantation, Florida, United States
Port Orange, Florida, United States
Marietta, Georgia, United States
Bloomington, Illinois, United States
Evansville, Indiana, United States
Leawood, Kansas, United States
Watertown, Massachusetts, United States
Las Vegas, Nevada, United States
New York, New York, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Altoona, Pennsylvania, United States
Austin, Texas, United States
El Paso, Texas, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Countries
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Other Identifiers
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BUP-305
Identifier Type: -
Identifier Source: org_study_id
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