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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01873365
First Posted: June 10, 2013
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention
Herpes Zoster Other: Data collection

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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 ]

Enrollment: 448
Study Start Date: June 2013
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01873365     History of Changes
Other Study ID Numbers: 200089
First Submitted: June 6, 2013
First Posted: June 10, 2013
Last Update Posted: January 18, 2017
Last Verified: January 2017

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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