EUCTR2009-014516-35-EE进行中（未招募）不适用
EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS
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
- 460
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
- •To be included in the trial, patients should fulfill the following criteria:
- •*male or female between 50 and 75 years of age
- •*presenting with medial femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness < 30 minutes)
- •- evolving for more than 6 months
- •- with a Womac pain score greater than or equal to 45 on a 100mm VAS
- •- patients taking analgesic medications for at least 3 months prior to inclusion and dissatisfied with their current therapy
- •- with a grade II or III according to the Kellgren and Lawrence radiological classification(1) on a posterio-anterior weight-bearing X-ray image of both knees performed at screening visit
- •*having given their written consent to take part in the study
- •*covered by social security or a health insurance policy (if required by local requirements).
- •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
- •Patients fulfilling at least one of the following criteria cannot be included in the study:
- •* Disease-related criteria:
- •- isolated symptomatic femoropatellar osteoarthritis or isolated lateral femorotibial OA of the knee
- •- Paget's disease of bone, chondromatosis or villonodular synovitis
- •- symptomatic hip OA
- •- inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…)
- •- hemochromatosis, ochronosis or hemophilia
- •- history of disease (except OA) which the investigator considers likely to interfere with the assessment of the functional disability
- •- Anticipated surgery of the knee during the course of the study
- •* Previous or concomitant treatment-related criteria:
- •- patient having taken a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulphate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion
- •- patient having taken bisphosphonates or strontium ranelate in the 3 months preceding inclusion
- •- patient having received any systemic corticosteroid treatment by any administration route during the month preceding inclusion
- •- patient having received intra-articular steroid injection in the target knee in the 2 months preceding inclusion or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding inclusion
- •- patient having taken NSAIDs (except aspirin up to 325 mg/day for cardiovascular prophylactic) in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 24 hours preceding inclusion
- •- patient having undergone surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) on the target knee
- •- patient having undergone articular lavage of target knee in the 3 months preceding inclusion
- •- patient with a known allergy to the study medication or one of its constituents
- •- patient requiring regular or intermittent steroid therapy.
- •* Patient-related criteria:
- •- Body mass index (BMI) greater than or equal to 35
- •- immunocompromised patient or patient presenting with a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic or infectious disease)
- •- patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation
- •- patient presenting laboratory test results out of acceptable ranges and considered as clinically significant by the investigator performed at screening
- •- patient presenting with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk
- •- patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion
- •- patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion
- •- patient linguistically or psychologically unable to understand and sign the consent form
- •- For women:
- •opregnant, breast feeding or likely to become pregnant during the time of the study
- •owomen with childbearing potential not using effective contraception (oral contraceptive formulations, intrauterine device, tubal ligation or other efficient procedures)
- •* Rescue medication-related criteria:
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