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

May 31, 2018 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

448

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Hokkaido, Japan, 085-0032
        • 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, 085-0036
        • 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
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: Approximately 1 year
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
Day 90 - Day 270

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of HZ-associated hospitalisations.
Time Frame: Day 0 - Day 270
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
Day 0 - Day 270
Anamnestic information, clinical parameters and complications related to HZ.
Time Frame: Day 0 - Day 270
Day 0 - Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Time Frame: Day 0 - Day 90
Day 0 - Day 90
Quality of life (QoL) assessment in HZ subjects.
Time Frame: Day 0 - Day 90
Day 0 - Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Time Frame: Day 90 - Day 270
Day 90 - Day 270
QoL assessment in PHN subjects.
Time Frame: Day 90 - Day 270
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
Day 0 - Day 270

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 29, 2013

Primary Completion (Actual)

February 4, 2015

Study Completion (Actual)

February 4, 2015

Study Registration Dates

First Submitted

June 6, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Actual)

June 1, 2018

Last Update Submitted That Met QC Criteria

May 31, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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