NCT02171182已完成不适用
A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
Astellas Pharma s.r.o.29 个研究点 分布在 1 个国家目标入组 319 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 319
- 试验地点
- 29
- 主要终点
- Percentage rate of responders
研究概览
简要总结
The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin patch in real-life clinical practice in the treatment of post-operative neuropathic pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed peripheral post-operative neuropathic pain
排除标准
- •hypersensitivity to capsaicin
- •pregnancy
- •diabetes mellitus
- •treatment of face
研究组 & 干预措施
Qutenza patients w/ post-operative peripheral neuropathic pain
干预措施: Qutenza (Drug)
结局指标
主要结局
Percentage rate of responders
时间窗: Baseline, Week 13
at least 30% decrease in pain intensity as compared to the baseline
次要结局
- Basic demographic parameters(Baseline)
- Previous treatment of neuropathy(Baseline)
- Reason for a change in the therapy(Baseline)
- Dose(Baseline, Week 13 and Week 26)
- Size of the area affected by neuropathic pain(Baseline, Week 13 and Week 26)
- Concomitant neuropathic medication(Baseline, Week 13 and Week 26)
- Efficacy of treatment(Baseline, Week 8, Week 13 and Week 26)
- Quality of life questionnaire (EQ-5D)(Baseline, Week 8, Week 13 and Week 26)
- Consumption of rescue analgesic medication(Baseline, Week 8, Week 13 and Week 26)
- Consumption of additional medical care for neuropathic pain(Baseline, Week 8, Week 13 and Week 26)
研究者
研究点 (29)
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