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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01873365
Enrollment
448
Registered
2013-06-10
Start date
2013-06-29
Completion date
2015-02-04
Last updated
2018-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Zoster

Keywords

Quality of life, Herpes zoster, Postherpetic neuralgia, Japan, Physician-practice, Adults, Health economics

Brief summary

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.

Interventions

OTHERData collection

Case report forms (CRFs), logbooks and booklets.

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
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
Occurrence of HZ-associated hospitalisations.Day 0 - 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
Direct medical, direct non-medical and indirect costs related to PHN.Day 90 - 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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026