Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive 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 75-600 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: 752.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CLBP; Chronic Low Back Pain; Chronic Pain; Back Pain

Summary:

      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.
    

Eligibility criteria:

        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