Flurbiprofen Tape for Treatment of Chronic Low Back Pain

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Low Back Pain

In brief

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).

Key facts

Study ID

NCT00759330

Run by

Teikoku Pharma USA, Inc.

People needed

127

Starts

2007-10-01

Expected to finish

2008-07-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Redpoint Research — Phoenix, Arizona, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• University Foundation for Education and Research, Inc. — Tampa, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Internal Medicine Associates of Cordova — Cordova, Tennessee, United States
• Sarah Cannon Research Institute — Memphis, Tennessee, United States
• Senior Adults Specialty Research — Austin, Texas, United States
• Charolettesville Medical Research — Charlottesville, Virginia, United States
• Rainier Clinical Research Center, Inc. — Renton, Washington, United States
• Aurora Advanced Healthcare, Inc. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.