NCT00171691已完成3 期
Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee
排除标准
- •Other rheumatic disease, such as rheumatoid arthritis
- •Active gastrointestinal ulcer during the last year
- •Known allergy to analgesic drugs
结局指标
主要结局
Incidence of treatment-emergent adverse events
Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
次要结局
- Incidence of serious treatment-emergent adverse events
- Number of patients who discontinued study medication due to a treatment-emergent adverse event
- WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12
研究者
研究点 (1)
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