NCT04421911已完成3 期
A Study to Comparing the Efficacy and Safety of the Ketoprofen and Diclofenac in Patients With Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 236
- 试验地点
- 9
- 主要终点
- Mean change in walking arthritis pain intensity score
研究概览
简要总结
Primary objective:
• To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of primary endpoint : Mean change in walking arthritis pain intensity score
Secondary objectives:
- To assess therapeutic efficacy of the Ketoprofen compared with Diclofenac based on the assessment of secondary endpoints.
- To assess safety and tolerability of the Ketoprofen compared with Diclofenac based on the nature and frequency of adverse events in treatment groups
详细描述
This trial is designed as an open-label, multicenter, randomized, clinical study for assessment of efficacy and safety of Ketoprofen plaster and Diclofenac plaster in patients with 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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40-75 years
- •Compliance to ACR diagnostic criteria of OA of the knee
- •Patients with Kellgren-Lawrence grade 1-3
- •Index knee pain should be ≥40 mm on VAS (100mm) scale
排除标准
- •Intolerance or allergic reactions to the study therapy
- •Usage of NSAIDs within 3 days
- •Open skin lesions or dermatological conditions at the site of plaster application
- •Surgery or major trauma of the index knee within the previous 12 months
- •Pregnant or breast-feeding women
- •Alcohol addiction, drug addiction or drug abuse in the past
研究组 & 干预措施
ketoprofen
Experimental
干预措施: Ketoprofen topical (Drug)
Diclofenac
Active Comparator
干预措施: Diclofenac Topical (Drug)
结局指标
主要结局
Mean change in walking arthritis pain intensity score
时间窗: 3 weeks
Pain will be assessed by a horizontal 100 mm Visual Analogue Scale (VAS)
次要结局
- Mean change in spontaneous arthritis pain intensity score(3 weeks)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(3 weeks)
- Global Impression of Improvement (PGI-I)(3 weeks)
- Adverse events(3 weeks)
研究者
研究点 (9)
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