NCT01873365已完成不适用
Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 448
- 试验地点
- 1
- 主要终点
- Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age.
研究概览
简要总结
The study aims to estimate the incidence of herpes zoster (HZ), proportion of postherpetic neuralgia (PHN) and the economic burden and impact on quality of life, in Japanese adults greater than or equal to sixty years of age.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •A male or female greater than or equal to sixty years of age, presenting with HZ at the time of enrollment.
- •HZ diagnosis.
- •Is the subject's first outpatient diagnosis for this HZ episode. OR
- •Took place up to seven days prior to the initial visit for the present study. Note: Recurrent HZ cases may be enrolled as new cases based on the investigator's clinical practice.
排除标准
- •Not applicable.
结局指标
主要结局
Total number of HZ cases reported in the study area, overall and within a specific age-group and gender. The following age-groups will be considered: 60-69, 70-79 and ≥ 80 years of age.
时间窗: Approximately 1 year
Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.
时间窗: Day 90 - Day 270
次要结局
- Occurrence of HZ-associated hospitalisations.(Day 0 - Day 270)
- Direct medical, direct non-medical and indirect costs related to HZ.(Day 0 - Day 90)
- Quality of life (QoL) assessment in HZ subjects.(Day 0 - Day 90)
- Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.(Day 0 - Day 270)
- Direct medical, direct non-medical and indirect costs related to PHN.(Day 90 - Day 270)
- QoL assessment in PHN subjects.(Day 90 - Day 270)
- Anamnestic information, clinical parameters and complications related to HZ.(Day 0 - Day 270)
- Impact of the following factors on the development of PHN: - age, - gender, - concomitant disease, - current immunosuppressive therapy, - HZ severity at first consultation, - timing of initiation of treatment with antiviral agent etc.(Day 0 - Day 270)
研究者
研究点 (1)
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