NCT02784691撤回不适用
Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Intensity reduction of pain
研究概览
简要总结
The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with age above 70 years,
- •Having a knee Arthritis (unilateral or bilateral) for at least 6 months,
- •Pain intensity ≥ 40 mm on a visual analog scale (VAS)
- •Lack of analgesic treatment or analgesic,
排除标准
- •Cognitive disorders : moderate to severe stage or not allowing an understanding of the VAS (as determined by the clinician)
- •A history of chronic inflammatory rheumatic disease,
- •Diagnosis of osteoarthritis of secondary origin,
- •Non-steroidal anti-inflammatory medication within 7 days prior to inclusion,
- •Diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure,
- •Allergy to diclofenac or similar activity substances such as other NSAIDs, aspirin, excipients,
- •Damaged skin
结局指标
主要结局
Intensity reduction of pain
时间窗: 2 days
Measured by Visual Analog Scale
次要结局
未报告次要终点
研究者
研究点 (2)
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