Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teikoku Pharma USA
ClinicalTrials.gov Identifier:
NCT00759330
First received: September 24, 2008
Last updated: June 14, 2012
Last verified: June 2012

September 24, 2008
June 14, 2012
October 2007
July 2008   (final data collection date for primary outcome measure)
Summed Pain Intensity Difference (SPID) [ Time Frame: Days 4 and 7 of treatment phase ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00759330 on ClinicalTrials.gov Archive Site
  • Categorical Pain Scale [ Time Frame: 12 and 24 hours daily for 7 days as determined by randomization group ] [ Designated as safety issue: No ]
  • Pain Intensity Difference (PID) [ Time Frame: 12 and 24 hours daily as determined by randomization group ] [ Designated as safety issue: No ]
  • Patient's Global Impression of Change (PGIC) [ Time Frame: Visit 3 (Day 21) ] [ Designated as safety issue: No ]
  • Functional Rating Index (FRI) [ Time Frame: Visit (Day 1), Visit 2 (Day 7), Visit 3 (Day 21) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Flurbiprofen Tape for Treatment of Chronic Low Back Pain
A Multi Center Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • Drug: Flurbiprofen Tape
    Two 31.5 mg Flurbiprofen Tape for 24 hour continuous administration for 7 day treatment phase
  • Drug: Flurbiprofen Placebo Tape
    Two Flurbiprofen Placebo Tapes for 12 hour continuous administration for 7 day treatment phase
  • Drug: Flurbiprofen Placebo Tape
    Two Flurbiprofen Placebo Tape for 24 hour continuous administration for 7 day treatment phase
  • Drug: Flurbiprofen Tape
    Two 31.5 mg Flurbiprofen Tapes for 12 hour continuous administration for 7 day treatment phase
  • Active Comparator: Flurbiprofen Tape (arm 2)
    Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 24 hour continuous administration
    Intervention: Drug: Flurbiprofen Tape
  • Placebo Comparator: Flurbiprofen Placebo (Arm 3)
    Daily dose Flurbiprofen Placebo Tape (2 tapes) for 12 hour continuous administration
    Intervention: Drug: Flurbiprofen Placebo Tape
  • Placebo Comparator: Flurbiprofen Placebo Tape (Arm 4)
    Daily dose Flubiprofen Placebo Tape (2 tapes) for 24 hour continuous administration
    Intervention: Drug: Flurbiprofen Placebo Tape
  • Active Comparator: Flurbiprofen Tape (Arm 1)
    Daily dose 63 mg Flurbiprofen Tape (2 tapes) for 12 hour continuous administration
    Intervention: Drug: Flurbiprofen Tape
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
July 2008
July 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759330
TPU FT-US06-01
No
Teikoku Pharma USA
Teikoku Pharma USA
Not Provided
Not Provided
Teikoku Pharma USA
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP