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

BioDelivery Sciences International

Status and phase

Completed

Phase 3

Conditions

Low Back Pain

Treatments

Drug: Buprenorphine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01675167

EN3409-307

Details and patient eligibility

About

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.

Enrollment

815 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 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