NCT00445276已完成4 期
Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
Laboratoires NEGMA2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2005年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- VAS on pain movement, WOMAC A 1.1 section
研究概览
简要总结
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Painful primary osteoarthritis (VAS ≥ 40 mm)
- •Radiologically proven (Kellgren & Lawrence grade I to III)
- •Requiring the prescription of a symptomatic treatment of pain
排除标准
- •Severe associated diseases
- •Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
- •Other osteoarticular disease
结局指标
主要结局
VAS on pain movement, WOMAC A 1.1 section
次要结局
- WOMAC : total, pain, physical function
- Paracetamol consumption
- Global assessment of the patient
- Responder patients with OMERACT-OARSI criteria
- Tolerance
研究者
研究点 (2)
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