Flurbiprofen Tape for Treatment of Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

— LBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759330
• Other study ID #: TPU FT-US06-01
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: June 14, 2012
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2012
• Source: Teikoku Pharma USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Drug:
• Flurbiprofen Tape
Two 31.5 mg Flurbiprofen Tape for 24 hour continuous administration for 7 day treatment phase
• Flurbiprofen Placebo Tape
Two Flurbiprofen Placebo Tapes for 12 hour continuous administration for 7 day treatment phase
• Flurbiprofen Placebo Tape
Two Flurbiprofen Placebo Tape for 24 hour continuous administration for 7 day treatment phase
• Flurbiprofen Tape
Two 31.5 mg Flurbiprofen Tapes for 12 hour continuous administration for 7 day treatment phase

Locations

Country	Name	City	State
United States	Senior Adult Specialty Research	Austin	Texas
United States	Charolettesville Medical Research Center	Charlottesville	Virginia
United States	Internal Medicine of Cordova	Cordova	Tennessee
United States	Sarah Cannon Research Institute	Memphis	Tennessee
United States	Aurora Advance Health Care	Milwaukee	Wisconsin
United States	Redpoint Research	Phoenix	Arizona
United States	Rainier Clinical Research Center	Renton	Washington
United States	University Foundation for Education Research	Tampa	Florida
United States	Diablo Clinical Research	Walnut Creek	California
United States	Palm Beach Clinical Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Teikoku Pharma USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summed Pain Intensity Difference (SPID)		Days 4 and 7 of treatment phase	No
Secondary	Categorical Pain Scale		12 and 24 hours daily for 7 days as determined by randomization group	No
Secondary	Pain Intensity Difference (PID)		12 and 24 hours daily as determined by randomization group	No
Secondary	Patient's Global Impression of Change (PGIC)		Visit 3 (Day 21)	No
Secondary	Functional Rating Index (FRI)		Visit (Day 1), Visit 2 (Day 7), Visit 3 (Day 21)	No