NCT00171678已完成3 期
Efficacy and 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
- 480
- 试验地点
- 1
- 主要终点
- WOMAC pain score in target knee at Week 12
研究概览
简要总结
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OA of the knee Key
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
WOMAC pain score in target knee at Week 12
WOMAC physical function score in target knee at Week 12
Global rating of disease activity by patient at Week 12
次要结局
- WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
- WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
- Pain on movement in target knee and use of rescue medication recorded in diary
- Global evaluation of treatment at final visit
- Treatment responder rate according to OARSI criteria
研究者
研究点 (1)
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