A Study to Assess the Burden of Herpes Zoster and Postherpetic Neuralgia in Japanese Adults Aged Sixty Years and Above

Study Overview
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Brief Summary
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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.

Official Title
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Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan

Conditions
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Herpes Zoster

Intervention / Treatment
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* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: • Not applicable.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective Group<br>Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ. | Other: Data collection<br>* Case report forms (CRFs), logbooks and booklets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | Approximately 1 year | 
| Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study. |  | Day 90 - Day 270 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of HZ-associated hospitalisations. |  | Day 0 - Day 270 | 
| Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study. |  | Day 0 - Day 270 | 
| Anamnestic information, clinical parameters and complications related to HZ. |  | 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 | 
| Direct medical, direct non-medical and indirect costs related to PHN. |  | Day 90 - Day 270 | 
| QoL assessment in PHN subjects. |  | Day 90 - 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quality of life, Herpes zoster, Postherpetic neuralgia, Japan, Physician-practice, Adults, Health economics