EUCTR2011-005661-20-IT进行中（未招募）不适用
A double-blind, randomised, parallel group, active controlled, multicentre study to assess the therapeutic non-inferiority of SKP-021, a 0.3% ketoprofen patch, versus diclofenac sodium patch in patients with painful and inflammatory conditions (e.g.: back pain, bruise, contusion, sprain, strains)
PROMO INTERNATIONAL SR0 个研究点开始时间: 2012年7月23日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Out-patients of both sexes, aged between 18-65 years, able to give informed consent and to complete the diary will be included if have traumatic disease (e.g.: bruise, contusion, sprain, etc.), with presenting frank symptoms of inflammation, such as pain (VAS >50mm), myalgia and swelling, within 2 days of suffering trauma; if the patient has more than one affected site, one alone is to be treated, whichever severe.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 680
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients will be excluded mainly if: too wide the affected site, needing other anti-inflammatory analgesic than the study drug for the underlying disease, obese, with history of drug allergy or with aspirin asthma, with a skin wound or skin disease at the test site, pregnancy or lactating women.
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