EUCTR2015-005681-37-BE
进行中（未招募）
1 期
Evaluation of the evolution of imaging markers of cartilage degradation in patients with knee osteoarthritis receiving DROGLICAN®: a Pilot Study - DRIP
BIOIBERICA S.A.0 个研究点目标入组 20 人2016年2月25日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Knee Osteoarthritis
- 发起方
- BIOIBERICA S.A.
- 入组人数
- 20
- 状态
- 进行中（未招募）
- 最后更新
- 7年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Male or female \= 40 years of age with BMI \= 40
- •Femorotibial knee OA (Uni\- or bilateral)
- •o Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- •o Symptomatic for more than 6 months in the most painful knee
- •o Radiological K\&L grade II\-III in radiographs from less than 12 months
- •Moderate\-to\-severe knee pain: knee pain score evaluated on VAS (0\-100\) \= 40 over the last 24 hours at the inclusion visit (the most painful knee is considered)
- •Able to follow the instructions of the study
- •Having signed an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •Related to the OA pathology
- •Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
- •Concurrent articular disease interfering with the evaluation of OA and/or pain such as articular dysplasia, aspectic osteonecrosis, acromegaly, Paget’s disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis , infectious arthritis, radiculalgia in the lower limbs, arteritis, etc.
- •Radiological K\&L grade I or IV
- •Prosthesis in the target knee
- •Related to treatments
- •Analgesics to manage OA knee pain (Paracetamol, oral NSAIDs, etc.) 24h before inclusion and any follow\-up visits
- •Corticosteroids injection in the target knee in the month preceding inclusion
- •Hyaluronan injection in the target knee in the last 6 months
- •Oral corticotherapy \= 5mg/day in the last 3 months
结局指标
主要结局
未指定
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