A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Tape for Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 10
- 主要终点
- Cumulative Summed Pain Intensity Difference (SPID+)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Tape (Arm 1)
Placebo tape remained on for 12 hours of continuous treatment per day.
干预措施: Placebo Tape (Arm 1) (Drug)
Flurbiprofen Tape (Arm 2)
Flurbiprofen tape remained on for 12 hours of continuous treatment per day.
干预措施: Flurbiprofen Tape (Arm 2) (Drug)
Placebo Tape (Arm 3)
Placebo tape remained on for 24 hours of continuous treatment per day.
干预措施: Placebo Tape (Arm 3) (Drug)
Flurbiprofen Tape (Arm 4)
Flurbiprofen tape remained on for 24 hours of continuous treatment per day.
干预措施: Flurbiprofen Tape (Arm 4) (Drug)
结局指标
主要结局
Cumulative Summed Pain Intensity Difference (SPID+)
时间窗: 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.
次要结局
- Average Daily Categorical Pain Scale Scores(Days 1 through 7 of tape treatment phase)
- Patient Global Impression of Change (PGIC)(Day 7)
- Change From Baseline in Total Tender Point Examination Score(Baseline to Day 7 of tape treatment phase)
- Pain Intensity Difference (PID+)(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)
- Acetaminophen Used During the Tape Treatment Phase(Day 1 through Day 7 of the tape treatment phase)
- Patient Assessment of Wearability of Therapy(Day 7)
- Percentage of Patients Who Discontinued(Days 1 through Day 7 of tape treatment phase)