Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

• Categorical Pain Scale [ Time Frame: 12 and 24 hours daily for 7 days as determined by randomization group ] [ Designated as safety issue: No ]
• Pain Intensity Difference (PID) [ Time Frame: 12 and 24 hours daily as determined by randomization group ] [ Designated as safety issue: No ]
• Patient's Global Impression of Change (PGIC) [ Time Frame: Visit 3 (Day 21) ] [ Designated as safety issue: No ]
• Functional Rating Index (FRI) [ Time Frame: Visit (Day 1), Visit 2 (Day 7), Visit 3 (Day 21) ] [ Designated as safety issue: No ]

The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than three months.

This study is a multi-center, randomized, double-blind, placebo-controlled study consisting of a 14 day baseline washout phase followed by a one week randomized Tape Treatment Phase of 24 or 12 continuous hours of tape use per day in subjects with chronic LBP.

• Drug: Flurbiprofen Tape
  Two 31.5 mg Flurbiprofen Tape for 24 hour continuous administration for 7 day treatment phase
• Drug: Flurbiprofen Placebo Tape
  Two Flurbiprofen Placebo Tapes for 12 hour continuous administration for 7 day treatment phase
• Drug: Flurbiprofen Placebo Tape
  Two Flurbiprofen Placebo Tape for 24 hour continuous administration for 7 day treatment phase
• Drug: Flurbiprofen Tape
  Two 31.5 mg Flurbiprofen Tapes for 12 hour continuous administration for 7 day treatment phase

• Active Comparator: Flurbiprofen Tape (arm 2)
  Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 24 hour continuous administration
  Intervention: Drug: Flurbiprofen Tape
• Placebo Comparator: Flurbiprofen Placebo (Arm 3)
  Daily dose Flurbiprofen Placebo Tape (2 tapes) for 12 hour continuous administration
  Intervention: Drug: Flurbiprofen Placebo Tape
• Placebo Comparator: Flurbiprofen Placebo Tape (Arm 4)
  Daily dose Flubiprofen Placebo Tape (2 tapes) for 24 hour continuous administration
  Intervention: Drug: Flurbiprofen Placebo Tape
• Active Comparator: Flurbiprofen Tape (Arm 1)
  Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 12 hour continuous administration
  Intervention: Drug: Flurbiprofen Tape

Inclusion Criteria:

• male or female 18 to 80 years;
• daily LBP below the 12th thoracic vertebra of greater than three months' duration;
• able to ambulate at least 100 meters;
• in stable general health
• no evidence of drug abuse or residual opiates ; determined by urine drug screening;
• diagnosis of chronic LBP verified by medical records;
• female subjects must be postmenopausal (defined as one year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Non-postmenopausal subjects must have confirmation of a negative urine pregnancy test;
• must read and speak English;
• must be reliable and mentally competent to complete study measurements;
• must be available for the study visits and telephone checks from study entry to study completion.
• male subjects must use an acceptable method of birth control with their female partners;
• rates their pain at 3 or higher on an eleven (11) point Categorical Pain Scale for LBP over the prior week (7 days) of Visit 1.
• discontinued the use of any topical pain medications, salves, anticonvulsants, oral NSAIDs, muscle relaxants, opioids, or anti-inflammatory steroids during the Baseline Phase. Acetaminophen, at a dose of < 1000 mg per day is acceptable;
• able to discontinue the use of therapy defined as ice, heat chiropractic care, physical therapy, acupuncture and acupressure on their lower back area during the Baseline Phase.

Exclusion Criteria:

• open skin lesion within the painful area;
• experiencing LBP for less than three months;
• undergone back surgery within the past three months or has plans for back surgery within 30 days post-study;
• 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 two times per week. Opioids and tramadol must not have been taken at least four days prior to study entry;
• had injection therapy, including corticosteroids;
• a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in DSM-IV);
• taking lithium, furosemide, and/or thiazides;
• 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 infraction (MI) and/or stroke within one (1) year of Visit 1