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

GlaxoSmithKline448 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

448

Conditions

Herpes Zoster

Interventions

Data collectionOTHER

Case report forms (CRFs), logbooks and booklets.

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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.

Locations (14)

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Hokkaido, Japan

Outcomes

Primary Outcomes

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.

Time frame: Approximately 1 year

Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.

Time frame: Day 90 - Day 270

Secondary Outcomes

Occurrence of HZ-associated hospitalisations.

Time frame: Day 0 - Day 270

Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.

Time frame: Day 0 - Day 270

Anamnestic information, clinical parameters and complications related to HZ.

Time frame: Day 0 - Day 270

Direct medical, direct non-medical and indirect costs related to HZ.

Time frame: Day 0 - Day 90

Quality of life (QoL) assessment in HZ subjects.

Time frame: Day 0 - Day 90

Direct medical, direct non-medical and indirect costs related to PHN.

Time frame: Day 90 - Day 270

QoL assessment in PHN subjects.

Time frame: 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.

Data from ClinicalTrials.gov

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