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



Status:Completed
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2012
End Date:June 2014

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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-Experienced Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia

The purpose of the study is to determine if buprenorphine hydrochloride (HCl) buccal film is
effective in treating opioid-experienced 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 ATC opioid analgesic medication
equivalent to ≥30 mg and ≤160 mg morphine sulfate equivalents (MSE) per day for ≥4
weeks. (Additional as needed [PRN] analgesic rescue medications permitted on top of
the stable daily maintenance dose of ≥30 mg MSE opioid analgesic, but must be
included in the total daily MSE calculation and in combination with the stable daily
maintenance dose not to exceed 160 mg MSE per day)

- Stable health, as determine by Principal Investigator

- Females are practicing abstinence, using a medically acceptable form of
contraception, or 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 within 6 months of screening

- Subjects with 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 of any opioid or acetaminophen

- Surgical procedure for relief of pain within 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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100 West Gore St # 202
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