Status:
COMPLETED
Flurbiprofen Tape for Treatment of Chronic Low Back Pain
Lead Sponsor:
Teikoku Pharma USA, Inc.
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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).
Detailed Description
This study is a multi-center, randomized, double-blind, placebo-controlled study in patients with daily low back pain below the 12th thoracic vertebra of greater than 3 months duration. Patients also ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00759330
Start Date
October 1 2007
End Date
July 1 2008
Last Update
October 6 2016
Active Locations (10)
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1
Redpoint Research
Phoenix, Arizona, United States, 85029
2
Diablo Clinical Research, Inc.
Walnut Creek, California, United States, 94598
3
University Foundation for Education and Research, Inc.
Tampa, Florida, United States, 33606
4
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409