Clinical trial NCT00759330: Flurbiprofen Tape for Treatment of Chronic Low Back Pain
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Low Back Pain
Keywords: Flurbiprofen, low back pain, chronic low back pain
Lead sponsor: Teikoku Pharma USA, Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 had an average daily pain score of 4 or greater on an 11-point categorical pain scale for the last 3 days of the baseline phase. The study began with a 14-day washout period of previously used pain medications. At the end of the 14-day baseline phase, patients were randomized to 1 of 4 treatments: Flurbiprofen tape applied once daily for 12 hours, Flurbiprofen tape applied once daily for 24 hours, placebo tape applied once daily for 12 hours, or placebo tape applied once daily for 24 hours. During the 7-day treatment phase, patients applied 2 treatment tapes once daily for 7 days. The tapes remained on for 12 or 24 hours of continuous treatment, depending on the treatment to which they were randomized. Patients were provided with rescue medication. After 7 days of tape treatment, patients returned to the clinic for a study exit visit.

Eligibility 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.

Primary outcomes:
measure: Cumulative Summed Pain Intensity Difference (SPID+)
timeFrame: Days 4 and 7 of tape treatment phase
Secondary outcomes:
measure: Pain Intensity Difference (PID+)
timeFrame: Days 1 through 7 of tape treatment phase
measure: Average Daily Categorical Pain Scale Scores
timeFrame: Days 1 through 7 of tape treatment phase
measure: Percent Change From Baseline in Total Functional Rating Index (FRI)
timeFrame: baseline to Day 7 of tape treatment phase
measure: Change From Baseline in Total Tender Point Examination Score
timeFrame: Baseline to Day 7 of tape treatment phase
measure: Patient Global Impression of Change (PGIC)
timeFrame: Day 7
measure: Acetaminophen Used During the Tape Treatment Phase
timeFrame: Day 1 through Day 7 of the tape treatment phase
measure: Acetaminophen Used During the Tape Treatment Phase
timeFrame: Day 1 through Day 7 of the tape treatment phase
measure: Percentage of Patients Who Discontinued
timeFrame: Days 1 through Day 7 of tape treatment phase
measure: Patient Assessment of Wearability of Therapy
timeFrame: Day 7
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Tampa
country: United States
facility: University Foundation for Education and Research, Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Cordova
country: United States
facility: Internal Medicine Associates of Cordova
state: Tennessee
city: Memphis
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Senior Adults Specialty Research
state: Texas
city: Charlottesville
country: United States
facility: Charolettesville Medical Research
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center, Inc.
state: Washington
city: Milwaukee
country: United States
facility: Aurora Advanced Healthcare, Inc.
state: Wisconsin
Study officials:
affiliation: Teikoku Pharma USA, Inc.
name: James Song
role: STUDY_DIRECTOR
References: