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

Completed · Phase 3 · Has a placebo group

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01633944

Run by

BioDelivery Sciences International

People needed

752

Starts

2012-08-01

Expected to finish

2013-12-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Global Research — Anaheim, California, United States
• Catalina Research Institute, LLC — Chino, California, United States
• Synergy Clinical Research Center of Escondido — Escondido, California, United States
• Adam D. Karns MD — Los Angeles, California, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Clinical Research of West Florida - Clearwater — Clearwater, Florida, United States
• Century Clinical Research, Inc. — Daytona Beach, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Florida Health Center — Fort Lauderdale, Florida, United States
• Eastern Research, Inc. — Hialeah, Florida, United States
• Florida Institute of Medical Research — Jacksonville, Florida, United States
• Drug Study Institute — Jupiter, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• NEMA Research, Inc. — Naples, Florida, United States
• Compass Research, LLC — Orlando, Florida, United States
• Peninsula Research — Ormond Beach, Florida, United States
• Gold Coast Research, L.L.C. — Plantation, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Clinical Research of West Florida - Tampa — Tampa, Florida, United States
• National Pain Research Institute, LLC — Winter Park, Florida, United States
• Atlanta Research Center — Atlanta, Georgia, United States
• River Birch Research Alliance, LLC — Blue Ridge, Georgia, United States
• Drug Studies America — Marietta, Georgia, United States
• Horizon Research Group, Inc./Alabama Orthopedic Clinic — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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