Flurbiprofen Tape for Treatment of Chronic Low Back Pain

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to evaluate the analgesic efficacy and safety of flurbiprofen tape for chronic low back pain (lasting greater than 3 months).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teikoku Pharma USA; Teikoku Pharma USA, Inc.
• Treatments: Flurbiprofen

Criteria

Inclusion Criteria:

• male or female 18 to 80 years;

• signed an informed consent;

• daily LBP below the 12th thoracic vertebra of greater than 3 months' duration;

• able to ambulate at least 100 meters;

• in stable general health with laboratory values within normal limits

• no evidence of drug abuse or residual opiates; determined by urine drug screening;

• diagnosis of chronic LBP verified by medical records;

• female patients must be postmenopausal (defined as 1 year without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Non-postmenopausal patients 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 patients must use an acceptable method of birth control with their female partners;

• rates their pain at 3 or higher on an 11-point Categorical Pain Scale for LBP over the prior week (7 days) of Visit 1.

• over the last 3 days of the Baseline Phase, had a computed average pain score of 4 or greater on an 11-point Categorical Pain Scale

• 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 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.