Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Pain, Low Back Pain

In brief

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

Key facts

Study ID

NCT01256450

Run by

BioDelivery Sciences International

People needed

334

Starts

2010-11-01

Expected to finish

2011-07-01

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…

• Male or non-pregnant and non-nursing female aged 18 or older
• History of moderate to severe chronic low back pain for ≥3 months with a pain intensity ≥5 [11 point numerical rating scale] reported at the open-label titration period Day 0/1 visit following a washout period (opioids, nonsteroidal anti-inflammatory drugs [NSAIDs], and muscle relaxants) of approximately 12 to 24 hours
• Currently taking ≤60 mg oral morphine/day or equianalgesic dose of another opioid (including opioid naïve) for 1 week or longer
• Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and screening laboratory results so as to comply with all study procedures
• Female subjects of childbearing potential must be using a recognized effective method of birth control
• Written informed consent obtained at Screening, prior to any procedure being performed

You may not qualify if…

• Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, and discitis
• Surgical procedure for back pain within 2 months prior to screening or nerve/plexus block within 4 weeks of screening
• Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia
• Corrected QT (QTc) interval of >450 milliseconds on the 12-lead electrocardiogram (ECG)
• History of long QT syndrome, or an immediate family member with this condition
• Diagnosis of moderate to severe hepatic impairment.
• History of severe emesis with opioids
• Clinically significant sleep apnea

Where it is running

• Alabama Orthopaedic Center - Research — Birmingham, Alabama, United States
• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• Arizona Research Center — Phoenix, Arizona, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• University of California, San Diego Medical Center, UCSD Center for Pain Medicine — La Jolla, California, United States
• Collaborative Neuroscience Network, Inc. — Long Beach, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Gold Coast Research, LLC — Plantation, Florida, United States
• Accord Clinical Research, LLC — Port Orange, Florida, United States
• Taylor Research, LLC — Marietta, Georgia, United States
• Millennium Pain Center — Bloomington, Illinois, United States
• MediSphere Medical Research Center, LLC — Evansville, Indiana, United States
• International Clinical Research Institute — Leawood, Kansas, United States
• MedVadis Research Corporation — Watertown, Massachusetts, United States
• Office of Stephen H. Miller, MD — Las Vegas, Nevada, United States
• Research Across American — New York, New York, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• The Center for Clinical Research, LLC — Winston-Salem, North Carolina, United States
• Allegheny Pain Management — Altoona, Pennsylvania, United States
• FutureSearch Trials of Neurology — Austin, Texas, United States
• Southwest Urgent Care Center — El Paso, Texas, United States
• Lifetree Clinical Research — Salt Lake City, Utah, United States
• Advanced Clinical Research — West Jordan, Utah, United States

Full record on ClinicalTrials.gov

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