Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis

Novartis138 个研究点分布在 1 个国家目标入组 360 人开始时间: 2005年5月1日最近更新: 2015年4月14日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Novartis
入组人数: 360
试验地点: 138
主要终点: OA pain intensity in target hand at Week 4 and 6

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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 hand 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: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Osteoarthritis of the hand

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

OA pain intensity in target hand at Week 4 and 6

Global rating of disease activity by patient at Week 4 and 6

Total AUSCAN score in target hand at Week 4 and 6

次要结局

Global evaluation of treatment at final visit
AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8
OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
OA pain intensity in target hand and use of rescue medication recorded in diary
Treatment responder rate according to OARSI criteria

研究者

发起方

Novartis

申办方类型

Industry

研究点 (138)

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