NCT01521286已完成不适用
Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.
研究概览
简要总结
The purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This study will also collect data on costs related to the HZ disease, especially postherpetic neuralgia (PHN)
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female >=50 years of age at the time of study enrolment presenting with acute HZ;
- •HZ diagnosis for this HZ episode;
- •is the subject's first outpatient diagnosis; OR
- •took place at another site/ centre up to seven days before the initial visit for the present study;
- •Ability to comply with study procedures*;
- •Written informed consent obtained from the subject*. Note: * will be applicable to secondary objectives only and not for the primary objective to calculate incidence.
排除标准
- •Subject participating in another research study. Note: This exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.
结局指标
主要结局
Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.
时间窗: up to one year
次要结局
- Occurrence of PHN, i.e. persistence of HZ-related pain.(90, 180, and 270 days after onset of HZ.)
- Anamnestic information, clinical parameters and complications related to HZ.(Between Day 0 and Day 270)
- Direct medical, direct non-medical and indirect costs related to HZ.(Between Day 0 and Day 90)
- Pain assessment in HZ subjects.(At Day 90)
- Quality of life assessment in HZ subjects(Day 15, Day 30, Day 60 and Day 90)
- Direct medical, direct non-medical and indirect costs related to PHN.(At Day 90, Day 180 and Day 270)
- Pain assessment in PHN subjects.(At Day 90, Day 180 and Day 270)
- Quality of life assessment in PHN subjects.(At Day 90, Day 180 and Day 270)
研究者
研究点 (1)
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