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Flurbiprofen Tape for Treatment of Chronic Low Back Pain

Information source: Teikoku Pharma USA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Low Back Pain

Intervention: Flurbiprofen Tape (Drug); Flurbiprofen Placebo Tape (Drug); Flurbiprofen Placebo Tape (Drug); Flurbiprofen Tape (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Teikoku Pharma USA

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 three months.

Clinical Details

Official title: A Multi Center Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain (LBP)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Summed Pain Intensity Difference (SPID)

Secondary outcome:

Categorical Pain Scale

Pain Intensity Difference (PID)

Patient's Global Impression of Change (PGIC)

Functional Rating Index (FRI)

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): 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

Locations and Contacts

Redpoint Research, Phoenix, Arizona 85029, United States

Diablo Clinical Research, Walnut Creek, California 94598, United States

University Foundation for Education Research, Tampa, Florida 33606, United States

Palm Beach Clinical Research, West Palm Beach, Florida 33409, United States

Internal Medicine of Cordova, Cordova, Tennessee 38018, United States

Sarah Cannon Research Institute, Memphis, Tennessee 38119, United States

Senior Adult Specialty Research, Austin, Texas 78757, United States

Charolettesville Medical Research Center, Charlottesville, Virginia 22911, United States

Rainier Clinical Research Center, Renton, Washington 98055, United States

Aurora Advance Health Care, Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: October 2007
Last updated: June 14, 2012

Page last updated: August 23, 2015

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