Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Experienced Subjects
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: Buprenorphine; Placebo
Intervention description: Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily; Matching Placebo Buccal Film twice daily
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 815.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLBP; Chronic Low Back Pain; Chronic Pain; Back Pain

Summary:

      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.
    

Eligibility criteria:

        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