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

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ClinicalTrials.gov Identifier: NCT01873365

Recruitment Status : Completed

First Posted : June 10, 2013

Last Update Posted : June 1, 2018

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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.

Condition or disease	Intervention/treatment
Herpes Zoster	Other: Data collection

Study Design


Study Type :	Observational
Actual Enrollment :	448 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Physician-practice Based Cohort Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Japan
Study Start Date :	June 29, 2013
Actual Primary Completion Date :	February 4, 2015
Actual Study Completion Date :	February 4, 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Shingles

MedlinePlus related topics: Shingles

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Prospective Group Japanese adults, aged greater than or equal to sixty years, diagnosed with HZ.	Other: Data collection Case report forms (CRFs), logbooks and booklets.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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. [ Time Frame: Day 0 - Day 270 ]

Eligibility Criteria

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Ages Eligible for Study:	60 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Japanese adults, male or female, greater than or equal to sixty years of age, presenting with HZ at the participating sites.

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873365

Locations


Japan
GSK Investigational Site
Hokkaido, Japan, 084-0906
GSK Investigational Site
Hokkaido, Japan, 084-0909
GSK Investigational Site
Hokkaido, Japan, 084-0912
GSK Investigational Site
Hokkaido, Japan, 085-0014
GSK Investigational Site
Hokkaido, Japan, 085-0032
GSK Investigational Site
Hokkaido, Japan, 085-0036
GSK Investigational Site
Hokkaido, Japan, 085-0052
GSK Investigational Site
Hokkaido, Japan, 085-0057
GSK Investigational Site
Hokkaido, Japan, 085-0062
GSK Investigational Site
Hokkaido, Japan, 085-0063
GSK Investigational Site
Hokkaido, Japan, 085-0805
GSK Investigational Site
Hokkaido, Japan, 085-0813
GSK Investigational Site
Hokkaido, Japan, 085-0822
GSK Investigational Site
Hokkaido, Japan, 085-8533

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mizukami A, Sato K, Adachi K, Matthews S, Holl K, Matsuki T, Kaise T, Curran D. Impact of Herpes Zoster and Post-Herpetic Neuralgia on Health-Related Quality of Life in Japanese Adults Aged 60 Years or Older: Results from a Prospective, Observational Cohort Study. Clin Drug Investig. 2018 Jan;38(1):29-37. doi: 10.1007/s40261-017-0581-5.

Nakamura H, Mizukami A, Adachi K, Matthews S, Holl K, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Sato K, Matsuki T, Kaise T, Curran D. Economic Burden of Herpes Zoster and Post-Herpetic Neuralgia in Adults 60 Years of Age or Older: Results from a Prospective, Physician Practice-Based Cohort Study in Kushiro, Japan. Drugs Real World Outcomes. 2017 Dec;4(4):187-198. doi: 10.1007/s40801-017-0119-4.

Sato K, Adachi K, Nakamura H, Asano K, Watanabe A, Adachi R, Kiuchi M, Kobayashi K, Matsuki T, Kaise T, Gopala K, Holl K. Burden of herpes zoster and postherpetic neuralgia in Japanese adults 60 years of age or older: Results from an observational, prospective, physician practice-based cohort study. J Dermatol. 2017 Apr;44(4):414-422. doi: 10.1111/1346-8138.13639. Epub 2016 Dec 5.


Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01873365 History of Changes
Other Study ID Numbers:	200089
First Posted:	June 10, 2013 Key Record Dates
Last Update Posted:	June 1, 2018
Last Verified:	May 2018

Keywords provided by GlaxoSmithKline:


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

Additional relevant MeSH terms:


Neuralgia Herpes Zoster Neuralgia, Postherpetic Pain Neurologic Manifestations Nervous System Diseases	Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Herpesviridae Infections DNA Virus Infections Virus Diseases

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