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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioDelivery Sciences International; Endo Pharmaceuticals
• Collaborator: BioDelivery Sciences International
• Treatments: Buprenorphine

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