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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873365
• Other study ID #: 200089
• Status: Completed
• Start date: June 29, 2013
• Est. completion date: February 4, 2015

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: February 4, 2015
• Est. primary completion date: February 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic

Intervention

Other:
• Data collection
Case report forms (CRFs), logbooks and booklets.

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido
Japan	GSK Investigational Site	Hokkaido

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Occurrence of HZ-associated PHN pain, persisting between 90 and 270 days after the initial visit for this study.		Day 90 - Day 270
Secondary	Occurrence of HZ-associated hospitalisations.		Day 0 - Day 270
Secondary	Occurrence of HZ-associated any pain, persisting between 0 and 270 days after the initial visit for this study.		Day 0 - Day 270
Secondary	Anamnestic information, clinical parameters and complications related to HZ.		Day 0 - Day 270
Secondary	Direct medical, direct non-medical and indirect costs related to HZ.		Day 0 - Day 90
Secondary	Quality of life (QoL) assessment in HZ subjects.		Day 0 - Day 90
Secondary	Direct medical, direct non-medical and indirect costs related to PHN.		Day 90 - Day 270
Secondary	QoL assessment in PHN subjects.		Day 90 - Day 270
Secondary	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