Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects



Status:Completed
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:December 2013

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Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film
is effective in treating opioid-naive subjects, with moderate to severe chronic low back
pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended
period of time.


Inclusion Criteria:

- Diagnosis of moderate to severe low back pain for ≥6 months

- Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication
up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as
needed [PRN] non-opioid analgesic medications permitted on top of the stable daily
maintenance dose of non-opioid analgesic)

- Stable health, as determined by Principal Investigator

- Are female who are practicing abstinence or using a medically acceptable form of
contraception or have been post-menopausal, biologically sterile, or surgically
sterile for more than 1 year

- Willing and able to comply with all protocol required visits and assessments

Exclusion Criteria:

- Current cancer related pain or received chemotherapy with 6 months of screening

- Receiving opioid analgesic medication >10 mg MSE per day within 28 days of screening

- Subjects with a history of other chronic painful conditions

- Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda
equina compression, acute nerve root compression, meningitis, or discitis

- Allergy or contraindications to any opioid or acetaminophen

- Surgical procedure for relief of pain with 6 months

- Hypokalemia or clinically unstable cardiac disease, including: unstable atrial
fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active
myocardial ischemia

- QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the
12-lead electrocardiogram (ECG)

- History of long QT syndrome or a family member with this condition

- Moderate to severe hepatic impairment

- Moderate to severe renal impairment

- Current or past history of alcohol abuse

- Positive urine toxicology screen for drug of abuse

- History or abnormalities on physical exam, vital signs, electrocardiogram, or
laboratory values
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Daytona Beach, Florida 32117
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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4243 Sunbeam Road
Jacksonville, Florida 32257
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400 Tower Rd Ne
Marietta, Georgia 30060
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4720 S. Western Avenue
Oklahoma City, Oklahoma 73109
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1044 SW 44th Street
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405-616-4888
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
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5430 Fredericksburg Road
San Antonio, Texas 78229
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Anaheim, California 92804
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Atlanta, Georgia 30319
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Bay City, Michigan 48706
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Beavercreek, Ohio 45432
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