EUCTR2007-001168-55-DE进行中（未招募）不适用
A Multi Center Randomized, Double-Blind, Placebo-Controlled Trial of Flurbiprofen Patch for Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be considered eligible for entry into the Baseline Phase (Visit 1) of the study if the following inclusion criteria are satisfied.
- •1.Patient must have given his/her written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures
- •2.Patient must be able to understand and follow instructions and to participate in the study for the entire period
- •3.Patient is male or female 18 to 80 years of age, inclusive at the time of Visit 1
- •4.Patient has a Body Mass Index (BMI) of 18-32 kg/m², inclusive at screening, and a total body weight = 55 kg
- •5.Female patients must be postmenopausal (defined as two years without menses), physically incapable of becoming pregnant, or using an acceptable birth control method. Acceptable methods of birth control with a low failure rate (less than 1%) are such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), or double-barrier methods (condom or diaphragm with spermicidal agent or IUD), sexual abstinence or vasectomised partner. Non-postmenopausal patients must have confirmation of a negative pregnancy test at Visit 1.
- •6.Patient has had daily LBP below the 12th thoracic vertebra of greater than three months’ duration
- •7.Patient is able to ambulate at least 100 meters
- •8.Patient is in stable general health with screening laboratory values within two times the upper limit of normal
- •9.Patient has a diagnosis of chronic LBP verified by appropriate medical records, as needed
- •10.Male patients must use an acceptable method of birth control with their female partners
- •11.Patient has had average LBP over the prior week (7 days) to Visit 1 of grade 4 or higher on an eleven point Categorical Pain Scale
- •Patients must meet all previous inclusion criteria as well as the additional following criteria to be eligible for randomization into Patch Treatment Phase (Visit 2):
- •12.Patient has, over the last three days of the Baseline Phase, a computed average pain score of 5 or higher on an eleven point Categorical Pain Scale as identified in his/her Baseline Daily Diary
- •13.Patient has not used anticonvulsants, NSAIDs, and muscle relaxants from Visit 1 through the Baseline Phase. Paracetamol dose of = 3000 mg/day is acceptable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A patient is not eligible for participation in the study if any of the following exclusion criteria are met at the screening visit.
- •1.Patient has participated in another clinical trial during the preceding 30 days of study entry
- •2.Patient has donated approximately 500 ml blood or more in the preceding 4 weeks
- •3.Patient has had a febrile illness within 1 week before the start of the study
- •4.Patient has a history of clinically significant allergies including drug allergies
- •5.Patient has a history of allergic response(s) to flurbiprofen, other non-steroidal analgesic drugs (NSAID) or related drugs
- •6.Patient has a history of known sensitivities to adhesives and/or to inactive constituents of the FP
- •7.Patient has an open skin lesion within the painful area
- •8.Patient has undergone back surgery within the past three months or has plans for back surgery within 30 days post-study
- •9.Patient has chronic back pain which is due to fibromyalgia or connective tissue disorder (lupus, rheumatoid arthritis, ankylosing spondylitis, Reiter’s syndrome, etc.)
- •10.Patient has LBP due to malignancy, vertebral fracture, or infection
- •11.Patient has used anticonvulsants within 30 days before randomization for treatment (if used for pain) and throughout the study
- •12.Patient is using NSAIDs, and muscle relaxants from screening through the end of study participation (Paracetamol dose of = 3000 mg/day is acceptable)
- •13.Patient has used opioids (including low potency/low dose opioid combinations and tramadol) more than two times per week within 30 days of study entry. Opioids and tramadol must be discontinued at least four days prior to study entry
- •14.Patient has had injection therapy within 30 days of study entry, including corticosteroids
- •15.Patient has a clinically significant psychiatric disorder (severe depression, other Axis I or Axis II disorders as defined in DSM-IV)
- •16.Patient is taking lithium, furosemide, and/or thiazides
- •17.Pregnant or lactating women
- •18.Patient is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators
- •19.Patient has a prior history of gastrointestinal bleeds/ulcers or clinically significant liver/kidney disease
- •20.Patient has a coagulation disorder or is taking warfarin or other anticoagulants [a low dose of acetylic salicylic acid (= 100 mg) is acceptable]
- •21.Patient has clinically significant fluid retention, asthma, cardiovascular disease (CVD), hypertension, or heart failure
- •22.Patient has had coronary artery bypass surgery (CABG), cardiovascular thrombotic event, myocardial infraction (MI) and/or stroke within one year of Visit 1
- •23.Patient has unresolved litigation related to back injury or other pain complaints; however, settled disability claims/payments (Worker’s Compensation, state/federal/private disability plans) are allowed
- •24.Patient has a history of drug or alcohol addiction or abuse within the past year. Alcohol abuse defined as >14 drinks per week (1 drink= 360 ml beer, 120 ml wine, or 45 ml distilled spirits)
- •25.Patient is an employee or at least dependent of an investigator and/or the sponsor or of an institution directly involved in the study or other trials under the investigator’s direction
研究者
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