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

BioDelivery Sciences International

Status and phase: Completed; Phase 3

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: Buprenorphine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01633944

EN3409-308

Details and patient eligibility

About

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.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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752 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Twice Daily Dosing

Treatment:

Drug: Placebo

Buprenorphine HCl Buccal Film

Experimental group

Description:

Twice Daily Dosing

Treatment:

Drug: Buprenorphine