Chronic Low Back PainPhase 2LBPNCT00759330
Flurbiprofen Tape for Treatment of Chronic Low Back Pain
A Phase 2 study testing Flurbiprofen Tape (Arm 2) and Flurbiprofen Tape (Arm 4) in people with Chronic Low Back Pain, run by Teikoku Pharma USA, Inc. at 10 sites in United States.
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 3 months). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Flurbiprofen Tape (Arm 2) and Flurbiprofen Tape (Arm 4)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2007to Jul 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Charolettesville Medical Research
Charlottesville, Virginia, 22911
Internal Medicine Associates of Cordova
Cordova, Tennessee, 38018
Sarah Cannon Research Institute
Memphis, Tennessee, 38119
Aurora Advanced Healthcare, Inc.
Milwaukee, Wisconsin, 53209
Redpoint Research
Phoenix, Arizona, 85029
Rainier Clinical Research Center, Inc.
Renton, Washington, 98057
University Foundation for Education and Research, Inc.
Tampa, Florida, 33606
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
Palm Beach Research Center
West Palm Beach, Florida, 33409
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain
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).
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Placebo Tape (Arm 1), Flurbiprofen Tape (Arm 2), Placebo Tape (Arm 3), Flurbiprofen Tape (Arm 4)
- Keywords
- Flurbiprofen, low back pain, chronic low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Tape (Arm 1) | Placebo comparator | Placebo tape remained on for 12 hours of continuous treatment per day. Receives: Drug: Placebo Tape (Arm 1) |
| Flurbiprofen Tape (Arm 2) | Experimental | Flurbiprofen tape remained on for 12 hours of continuous treatment per day. Receives: Drug: Flurbiprofen Tape (Arm 2) |
| Placebo Tape (Arm 3) | Placebo comparator | Placebo tape remained on for 24 hours of continuous treatment per day. Receives: Drug: Placebo Tape (Arm 3) |
| Flurbiprofen Tape (Arm 4) | Experimental | Flurbiprofen tape remained on for 24 hours of continuous treatment per day. Receives: Drug: Flurbiprofen Tape (Arm 4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 4 and 7 of tape treatment phase
Secondary outcomes (9)
Pain Intensity Difference (PID+)
+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.
Measured: Days 1 through 7 of tape treatment phase
Average Daily Categorical Pain Scale Scores
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.
Measured: Days 1 through 7 of tape treatment phase
Percent Change From Baseline in Total Functional Rating Index (FRI)
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.
Measured: baseline to Day 7 of tape treatment phase
Change From Baseline in Total Tender Point Examination Score
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.
Measured: Baseline to Day 7 of tape treatment phase
Patient Global Impression of Change (PGIC)
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.
Measured: Day 7
Acetaminophen Used During the Tape Treatment Phase
The percentage of patients who used rescue medication during the tape treatment phase.
Measured: Day 1 through Day 7 of the tape treatment phase
Acetaminophen Used During the Tape Treatment Phase
The total amount (mg) of rescue medication used during the tape treatment phase.
Measured: Day 1 through Day 7 of the tape treatment phase
Percentage of Patients Who Discontinued
The percentage of patients who discontinued the study during the tape treatment phase due to lack of efficacy.
Measured: Days 1 through Day 7 of tape treatment phase
Patient Assessment of Wearability of Therapy
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.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teikoku Pharma USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Song, Study director, Teikoku Pharma USA, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759330
- Sponsor's protocol ID
- TPU FT-US06-01
- Other IDs
- NCT00759330
- Acronym
- LBP
- Status last verified
- Jun 2016
- First submitted
- 24 Sep 2008
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00759330
- Acronym / sponsor ID
- LBP / TPU FT-US06-01
- Conditions
- Chronic Low Back Pain
- Keywords
- Flurbiprofen, low back pain, chronic low back pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Teikoku Pharma USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Tape (Arm 1) | Placebo comparator | Drug: Placebo Tape (Arm 1)Placebo tape remained on for 12 hours of continuous treatment per day. |
| Flurbiprofen Tape (Arm 2) | Experimental | Drug: Flurbiprofen Tape (Arm 2)Flurbiprofen tape remained on for 12 hours of continuous treatment per day. |
| Placebo Tape (Arm 3) | Placebo comparator | Drug: Placebo Tape (Arm 3)Placebo tape remained on for 24 hours of continuous treatment per day. |
| Flurbiprofen Tape (Arm 4) | Experimental | Drug: Flurbiprofen Tape (Arm 4)Flurbiprofen tape remained on for 24 hours of continuous treatment per day. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (17 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Placebo Tape (Arm 1) |
| 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. | Drug | Flurbiprofen Tape (Arm 2) |
| 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. | Drug | Placebo Tape (Arm 3) |
| 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. | Drug | Flurbiprofen Tape (Arm 4) |
Primary outcome
Cumulative Summed Pain Intensity Difference (SPID+)
Time frame: Days 4 and 7 of tape treatment phase
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.
9 secondary outcomes
Pain Intensity Difference (PID+)
Time frame: Days 1 through 7 of tape treatment phase
Average Daily Categorical Pain Scale Scores
Time frame: Days 1 through 7 of tape treatment phase
Percent Change From Baseline in Total Functional Rating Index (FRI)
Time frame: baseline to Day 7 of tape treatment phase
Change From Baseline in Total Tender Point Examination Score
Time frame: Baseline to Day 7 of tape treatment phase
Patient Global Impression of Change (PGIC)
Time frame: Day 7
Acetaminophen Used During the Tape Treatment Phase
Time frame: Day 1 through Day 7 of the tape treatment phase
Acetaminophen Used During the Tape Treatment Phase
Time frame: Day 1 through Day 7 of the tape treatment phase
Percentage of Patients Who Discontinued
Time frame: Days 1 through Day 7 of tape treatment phase
Patient Assessment of Wearability of Therapy
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Song study director
Teikoku Pharma USA, Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flurbiprofen Tape (Arm 2) and Flurbiprofen Tape (Arm 4) in people with Chronic Low Back Pain, run by Teikoku Pharma USA, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Summed Pain Intensity Difference (SPID+) (time frame: Days 4 and 7 of tape treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.