Flurbiprofen Tape for Treatment of Chronic Low Back Pain

NCT00759330 | Completed Phase 2 Results

• 2 other identifiers: TPU FT-US06-01NCT00759330
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 10

Brief 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 3 months).

Conditions

Chronic Low Back Pain

Keywords

Flurbiprofen, low back pain, chronic low back pain

Outcome Measures

Primary Outcomes (1)

• Cumulative Summed Pain Intensity Difference (SPID+)

  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.

  Days 4 and 7 of tape treatment phase

Secondary Outcomes (9)

• Pain Intensity Difference (PID+)

  Days 1 through 7 of tape treatment phase

• Average Daily Categorical Pain Scale Scores

  Days 1 through 7 of tape treatment phase

• Percent Change From Baseline in Total Functional Rating Index (FRI)

  baseline to Day 7 of tape treatment phase

• Change From Baseline in Total Tender Point Examination Score

  Baseline to Day 7 of tape treatment phase

• Patient Global Impression of Change (PGIC)

  Day 7

Study Arms (4)

Placebo Tape (Arm 1)

PLACEBO COMPARATOR

Placebo tape remained on for 12 hours of continuous treatment per day.

Drug: Placebo Tape (Arm 1)

Flurbiprofen Tape (Arm 2)

EXPERIMENTAL

Flurbiprofen tape remained on for 12 hours of continuous treatment per day.

Drug: Flurbiprofen Tape (Arm 2)

Placebo Tape (Arm 3)

PLACEBO COMPARATOR

Placebo tape remained on for 24 hours of continuous treatment per day.

Drug: Placebo Tape (Arm 3)

Flurbiprofen Tape (Arm 4)

EXPERIMENTAL

Flurbiprofen tape remained on for 24 hours of continuous treatment per day.

Drug: Flurbiprofen Tape (Arm 4)

Interventions

Placebo Tape (Arm 1) DRUG

Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.

Placebo Tape (Arm 1)

Flurbiprofen Tape (Arm 2) DRUG

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.

Flurbiprofen Tape (Arm 2)

Placebo Tape (Arm 3) DRUG

Two placebo tapes (one on each side of the spine) were applied on the lower back area once daily for 7 days.

Placebo Tape (Arm 3)

Flurbiprofen Tape (Arm 4) DRUG

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.

Flurbiprofen Tape (Arm 4)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Teikoku Pharma USA, Inc.: lead

Study Sites (10)

Redpoint Research

Phoenix, Arizona, 85029, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

University Foundation for Education and Research, Inc.

Tampa, Florida, 33606, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Internal Medicine Associates of Cordova

Cordova, Tennessee, 38018, United States

Location

Sarah Cannon Research Institute

Memphis, Tennessee, 38119, United States

Location

Senior Adults Specialty Research

Austin, Texas, 78757, United States

Location

Charolettesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

Aurora Advanced Healthcare, Inc.

Milwaukee, Wisconsin, 53209, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Teikoku Pharma USA, Inc.

408-501-1821

Study Officials

• James Song

  Teikoku Pharma USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 6, 2016
• Results First Posted: October 6, 2016

Record last verified: 2016-06

Locations

US (10)