EUCTR2008-003875-35-DE进行中（未招募）不适用
Comparative study of efficacy and safety of GO-ON and Hyalgan in patients with symptomatic osteoarthritis of the knee.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
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 who fulfilled the following criteria are eligible:
- •patients who signed the informed consent to participate in the study,
- •female/male, age from 50 to 80 year inclusive,
- •patients with femorotibial OA of the knee. The diagnosis of knee osteoarthritis
- •will be based on the clinical and radiographic classification criteria developed
- •by the American College of Rheumatology (ACR) (Altman R. et al., 1986), i.e.:
- •- Knee pain,
- •- X-ray osteophytes and
- •- at least one of 3:
- •age >50 years and/or
- •morning stiffness <30 minutes duration
- •and/or crepitus on active motion,
- •patients with knee OA symptoms for at least six months and who failed to
- •respond (i.e. did not respond sufficiently) to analgesics and/or regular NSAIDs,
- •or are proved to be intolerant to the regular use of NSAIDs or weak opioids
- •analgesics,
- •patients with a global pain score = to 40 mm on a 0-100 mm VAS and a
- •WOMAC pain subscale score = 25 mm on a 0-100 normalized scale,
- •patients with Lequesne’s Index = 4,
- •patients with radiographic stage II or III according to the Kellgren and
- •Lawrence radiological classification (the relevant X-ray might have been
- •performed within the 12 months preceding the screening visit),
- •patients having X-ray or MRI confirmation of OA in the non-target (contralateral)
- •knee, may be enrolled in the trial as long as the target knee is the more
- •symptomatic knee and meets the criteria listed above. Pain in the non-signal
- •knee must be limited to <30mm at baseline on a 0-100 mm Huskisson VAS,
- •patients treated with SYSADOAs are eligible if the dosage has been stable at
- •least three months prior the screening visit
- •patients must be covered by the National Social Security insurance system
- •(only for French Patients).
- •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
- •The main exclusion criteria are the following:
- •isolated or predominantly symptomatic femoropatellar OA of the knee,
- •evidence of secondary osteoarthritis,
- •rheumatic diseases other than osteoarthritis,
- •with clinical joint effusion” of the target knee on the day of screening,
- •history of allergy or known hypersensitivity to hyaluronic acid and/or hypersensitivity to any of the components of the products under study,
- •patients in which both rescue medications (paracetamol/NSAID) are contraindicated,
- •any significant health problem,
- •known hepatic function abnormalities,
- •skin infection or disease at the injection site,
- •use of any experimental drug within the previous 3 months,
- •obese patients (BMI =32),
- •patients who have been treated with:
- •-intra-articular steroid during the previous month or systemic steroid drugs within the 3 months preceding randomization and/or
- •-intra-articular hyaluronic acid in the target knee during the previous 12 months,
- •ongoing anticoagulant treatment (except patients on low dose aspirin, not exceeding 325 mg per day),
- •patients with symptomatic hip OA homolateral to the target knee,
- •pregnant or lactating women, and women of childbearing potential (using adequate contraceptive method for at least 1 year) not willing to keep on using adequate contraceptive method for the duration of the study,
- •perceived inability/unwillingness to fully comply with all protocol requirements.
- •Patients who underwent extensive surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) and/or uncomplicated meniscectomy if performed within the last 12 months before the screening visit of the target knee. [Even if meniscectomy is a RISK FACTOR for knee OA, it is not considered an exclusion criteria if performed > 12 months before the screening visit].
- •Patients who have received any investigational drug/device within 3 months prior to the screening visit and/or patients who are scheduled to take part in other clinical trial during the course of this trial.
- •Patients with a severe concomitant disease at any organ or apparatus (including acute or chronic infective diseases) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the trial and/or current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy (excluding basal cell or squamous cell carcinoma of the skin).
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