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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
  Purpose

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.


Condition Intervention Phase
Chronic Low Back Pain
Drug: Flurbiprofen Tape
Drug: Flurbiprofen Placebo Tape
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi Center Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 127
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Flurbiprofen Tape (arm 2)
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
Placebo Comparator: Flurbiprofen Placebo (Arm 3)
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
Placebo Comparator: Flurbiprofen Placebo Tape (Arm 4)
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
Active Comparator: Flurbiprofen Tape (Arm 1)
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
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Arizona
Redpoint Research
Phoenix, Arizona, United States, 85029
United States, California
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Florida
University Foundation for Education Research
Tampa, Florida, United States, 33606
Palm Beach Clinical Research
West Palm Beach, Florida, United States, 33409
United States, Tennessee
Internal Medicine of Cordova
Cordova, Tennessee, United States, 38018
Sarah Cannon Research Institute
Memphis, Tennessee, United States, 38119
United States, Texas
Senior Adult Specialty Research
Austin, Texas, United States, 78757
United States, Virginia
Charolettesville Medical Research Center
Charlottesville, Virginia, United States, 22911
United States, Washington
Rainier Clinical Research Center
Renton, Washington, United States, 98055
United States, Wisconsin
Aurora Advance Health Care
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Teikoku Pharma USA
  More Information

No publications provided

Responsible Party: Teikoku Pharma USA
ClinicalTrials.gov Identifier: NCT00759330     History of Changes
Other Study ID Numbers: TPU FT-US06-01
Study First Received: September 24, 2008
Last Updated: June 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Teikoku Pharma USA:
Flurbiprofen, low back pain ,chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Flurbiprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014