Flurbiprofen Tape for Treatment of Chronic Low Back Pain

Exclusion Criteria

• •open skin lesion within the painful area;
• •experiencing LBP for less than 3 months;
• •undergone back surgery within the past 3 months or has plans for back surgery within 30 days post-study;
• •participated in clinical treatment studies within 30 days of study entry;
• •chronic back pain which is due to fibromyalgia or connective tissue disorder (lupus, rheumatoid arthritis, ankylosing spondylitis, Reiter's syndrome, etc.);
• •LBP due to malignancy, vertebral fracture, or infection;
• •used opioids (including low potency/low dose opioid combinations and tramadol) more than 2 times per week within 30 days of study entry. Opioids and tramadol must not have been taken at least 4 days prior to study entry;
• •had injection therapy within 30 days of study entry, including corticosteroids;
• •a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV);
• •taking lithium, furosemide, and/or thiazides;
• •considered unreliable as to medication compliance (if any medication other than 1000 mg or less of acetaminophen a day was taken for any type of pain, the patient was discontinued) or adherence to scheduled appointments as determined by the investigators;
• •a prior history of GI bleeds/ulcers or clinically significant liver/kidney disease;
• •known hypersensitivity to flurbiprofen or other NSAIDs;
• •has a coagulation disorder or is taking warfarin or other anticoagulants (aspirin at a dose of \[≤ 81 mg\] is acceptable);
• •clinically significant fluid retention, cardiovascular disease (CVD), hypertension, or heart failure;
• •had coronary artery bypass graft surgery (CABG), cardiovascular thrombotic event, myocardial infarction (MI) and/or stroke within 1 year of Visit 1;
• •had unresolved litigation related to back injury or other pain complaints; settled disability claims/payments (Worker's Compensation, state/federal/private disability plans) were allowed.