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• Purpose

  click on markers to display additional information

  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)

  
  

  status:	completed
  conditions:	Chronic Low Back Pain
  interventions:	Flurbiprofen Tape ; Flurbiprofen Placebo Tape ; Flurbiprofen Placebo Tape ; Flurbiprofen Tape
  phase:	Phase 2
  study type:	Interventional
  study design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
  official title:	A Multi Center Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

• Further study details (as provided by Teikoku Pharma USA)

  primary outcome measures:

  • Summed Pain Intensity Difference (SPID) [ Time Frame: Days 4 and 7 of treatment phase ]

  secondary outcome measures:

  • Categorical Pain Scale [ Time Frame: 12 and 24 hours daily for 7 days as determined by randomization group ]
  • Pain Intensity Difference (PID) [ Time Frame: 12 and 24 hours daily as determined by randomization group ]
  • Patient's Global Impression of Change (PGIC) [ Time Frame: Visit 3 (Day 21) ]
  • Functional Rating Index (FRI) [ Time Frame: Visit (Day 1), Visit 2 (Day 7), Visit 3 (Day 21) ]

  enrollment: 120

  study start date: October 2007

  study completion date: July 2008

  
  

  Arms	Assigned Interventions
  Flurbiprofen Tape (arm 2): Active Comparator Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 24 hour continuous administration	Drug: Flurbiprofen Tape Two 31.5 mg Flurbiprofen Tape for 24 hour continuous administration for 7 day treatment phase
  Flurbiprofen Placebo (Arm 3): Placebo Comparator Daily dose Flurbiprofen Placebo Tape (2 tapes) for 12 hour continuous administration	Drug: Flurbiprofen Placebo Tape Two Flurbiprofen Placebo Tapes for 12 hour continuous administration for 7 day treatment phase
  Flurbiprofen Placebo Tape (Arm 4): Placebo Comparator Daily dose Flubiprofen Placebo Tape (2 tapes) for 24 hour continuous administration	Drug: Flurbiprofen Placebo Tape Two Flurbiprofen Placebo Tape for 24 hour continuous administration for 7 day treatment phase
  Flurbiprofen Tape (Arm 1): Active Comparator Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 12 hour continuous administration	Drug: Flurbiprofen Tape Two 31.5 mg Flurbiprofen Tapes for 12 hour continuous administration for 7 day treatment phase

  Detailed description

  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.
  

• Eligibility

  ages eligible for study:	18 Years to 80 Years
  genders eligible for study:	Both

  Criteria

  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

• Contacts and locations

  Please refer to this study by its ClinicalTrials.gov identifier: NCT00759330

  Locations

  United States , Arizona  - Redpoint Research

  facility:

  Phoenix, Arizona, United States, 85029

  
  

  United States , California  - Diablo Clinical Research

  facility:

  Walnut Creek, California, United States, 94598

  
  

  United States , Florida  - University Foundation for Education Research

  facility:

  Tampa, Florida, United States, 33606

  
  

  United States , Florida  - Palm Beach Clinical Research

  facility:

  West Palm Beach, Florida, United States, 33409

  
  

  United States , Tennessee  - Sarah Cannon Research Institute

  facility:

  Memphis, Tennessee, United States, 38119

  
  

  United States , Tennessee  - Internal Medicine of Cordova

  facility:

  Cordova, Tennessee, United States, 38018

  
  

  United States , Texas  - Senior Adult Specialty Research

  facility:

  Austin, Texas, United States, 78757

  
  

  United States , Virginia  - Charolettesville Medical Research Center

  facility:

  Charlottesville, Virginia, United States, 22911

  
  

  United States , Washington  - Rainier Clinical Research Center

  facility:

  Renton, Washington, United States, 98055

  
  

  United States , Wisconsin  - Aurora Advance Health Care

  facility:

  Milwaukee, Wisconsin, United States, 53209

  
  

• Sponsors and collaborators

  Teikoku Pharma USA
  

• More information

  first received:	September 24, 2008
  last updated:	September 24, 2008
  ClinicalTrials.gov Identifier:	NCT00759330
  health authority:	United States: Food and Drug Administration

Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

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