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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: August 12, 2016
Last verified: June 2016
  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 3 months).

Condition Intervention Phase
Chronic Low Back Pain
Drug: Placebo Tape (Arm 1)
Drug: Flurbiprofen Tape (Arm 2)
Drug: Placebo Tape (Arm 3)
Drug: Flurbiprofen Tape (Arm 4)
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

Resource links provided by NLM:


Further study details as provided by Teikoku Pharma USA:

Primary Outcome Measures:
  • Cumulative Summed Pain Intensity Difference (SPID+) [ Time Frame: Days 4 and 7 of tape treatment phase ] [ Designated as safety issue: No ]

    The primary efficacy endpoint was the cumulative summed pain intensity difference (SPID+) at Days 4 and 7 of the tape treatment phase as computed from the daily categorical pain scale score reported on the patient's daily diary during the tape treatment phase; pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.

    Summed pain intensity difference is the sum of the pain intensity differences (PID). PID at each post-baseline evaluation was computed as the average baseline categorical pain scale score minus the post-baseline categorical pain scale score from the daily dairy. For patients with multiple pain scores reported on a given post-baseline study day, the PID scores were averaged to compute one daily PID score for each patient.



Secondary Outcome Measures:
  • Pain Intensity Difference (PID+) [ Time Frame: Days 1 through 7 of tape treatment phase ] [ Designated as safety issue: No ]

    +PID = pre-treatment value at baseline - post-treatment value at day of evaluation, where: pre-treatment value at baseline = average daily pain over the last 3 days of the baseline phase (ie, average of daily averages of the categorical pain scale scores for the last 3 days of the baseline phase). Pain was rated on an 11-point scale, where: 0 = no pain, 10 = worst pain imaginable.

    A positive PID indicates a reduction in pain.


  • Average Daily Categorical Pain Scale Scores [ Time Frame: Days 1 through 7 of tape treatment phase ] [ Designated as safety issue: No ]

    Patients rated their lower back pain, caused by normal activity and movement, on an 11-point categorical pain scale, where:

    0 = no pain, and 10 = worst pain imaginable. Patients rated their lower back pain every 12 hours, at any time they took medication including rescue medication for any type of pain, and if they applied or removed their treatment tapes at a time other than the scheduled time.

    Data are reported as the daily average categorical pain scale score by treatment group.


  • Percent Change From Baseline in Total Functional Rating Index (FRI) [ Time Frame: baseline to Day 7 of tape treatment phase ] [ Designated as safety issue: No ]

    Patients completed the FRI, a 10-item back pain-specific measure of function questionnaire describing the condition at the time the questionnaire was completed; each item (pain intensity, sleeping, personal care, travel, etc.) was rated on a 5-point scale, where 0 = best outcome, 4 = worst outcome.

    FRI was reported as the percent change from baseline at Day 7 of the tape treatment phase, where:

    Total FRI score = sum of the 10 questions. The total FRI score ranged from 0 (best outcome) to 40 (worst outcome). Percent change = ([baseline - Day 7]/baseline)*100.

    A positive percent change indicates a favorable treatment effect.


  • Change From Baseline in Total Tender Point Examination Score [ Time Frame: Baseline to Day 7 of tape treatment phase ] [ Designated as safety issue: No ]

    At baseline and Day 7 of the tape treatment phase, patients had an assessment of tenderness bilaterally at the sacroiliac joint, greater trochanter of the hip, gluteus medius and minimus, and paraspinal muscles at L3-L4, L4-L5, and L5-S1. The investigator or research nurse pressed 12 specific areas of the body (6 locations, left and right sides), and patients were asked to rate the intensity of their pain at those 12 areas using an 11-point scale, where:

    0 = no pain, 10 = the worst pain the patient has ever experienced. The total tender point examination score ranged from 0 (best outcome) to 120 (worst outcome). Change from baseline = baseline - Day 7. A positive change indicates a favorable treatment effect.


  • Patient Global Impression of Change (PGIC) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    At Day 7, patients provided their PGIC with regard to lower back pain response to treatment, using a 7-point scale, where:

    1 = very much improved, 7 = very much worse.


  • Acetaminophen Used During the Tape Treatment Phase [ Time Frame: Day 1 through Day 7 of the tape treatment phase ] [ Designated as safety issue: No ]
    The percentage of patients who used rescue medication during the tape treatment phase.

  • Acetaminophen Used During the Tape Treatment Phase [ Time Frame: Day 1 through Day 7 of the tape treatment phase ] [ Designated as safety issue: No ]
    The total amount (mg) of rescue medication used during the tape treatment phase.

  • Percentage of Patients Who Discontinued [ Time Frame: Days 1 through Day 7 of tape treatment phase ] [ Designated as safety issue: No ]
    The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.

  • Patient Assessment of Wearability of Therapy [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

    At Day 7, patients assessed the wearability of their treatment tape (ease of application, stays in place, comfortable to wear) using a 4-point scale, where:

    1 = Excellent, 4 = Poor.



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
Placebo Comparator: Placebo Tape (Arm 1)
Placebo tape remained on for 12 hours of continuous treatment per day.
Drug: Placebo Tape (Arm 1)
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
Experimental: Flurbiprofen Tape (Arm 2)
Flurbiprofen tape remained on for 12 hours of continuous treatment per day.
Drug: Flurbiprofen Tape (Arm 2)
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.
Placebo Comparator: Placebo Tape (Arm 3)
Placebo tape remained on for 24 hours of continuous treatment per day.
Drug: Placebo Tape (Arm 3)
Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.
Experimental: Flurbiprofen Tape (Arm 4)
Flurbiprofen tape remained on for 24 hours of continuous treatment per day.
Drug: Flurbiprofen Tape (Arm 4)
Two flurbiprofen tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days. Each tape contained 31.5 mg flurbiprofen for a total daily dose of 63 mg.

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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, Inc.
Walnut Creek, California, United States, 94598
United States, Florida
University Foundation for Education and Research, Inc.
Tampa, Florida, United States, 33606
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Tennessee
Internal Medicine Associates of Cordova
Cordova, Tennessee, United States, 38018
Sarah Cannon Research Institute
Memphis, Tennessee, United States, 38119
United States, Texas
Senior Adults Specialty Research
Austin, Texas, United States, 78757
United States, Virginia
Charolettesville Medical Research
Charlottesville, Virginia, United States, 22911
United States, Washington
Rainier Clinical Research Center, Inc.
Renton, Washington, United States, 98057
United States, Wisconsin
Aurora Advanced Healthcare, Inc.
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
Teikoku Pharma USA
Investigators
Study Director: James Song Teikoku Pharma USA
  More Information

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
Results First Received: May 13, 2016
Last Updated: August 12, 2016
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
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Flurbiprofen
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 07, 2016