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Completed

NCT Number: NCT01873365

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

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.

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Key information

Conditions

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

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Hokkaido, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

Case report forms (CRFs), logbooks and booklets.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Occurrence of HZ-associated hospitalisations.

    Time frame: Day 0 - Day 270

  2. 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

  3. Anamnestic information, clinical parameters and complications related to HZ.

    Time frame: Day 0 - Day 270

  4. Direct medical, direct non-medical and indirect costs related to HZ.

    Time frame: Day 0 - Day 90

  5. Quality of life (QoL) assessment in HZ subjects.

    Time frame: Day 0 - Day 90

  6. Direct medical, direct non-medical and indirect costs related to PHN.

    Time frame: Day 90 - Day 270

  7. QoL assessment in PHN subjects.

    Time frame: Day 90 - Day 270

  8. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 10, 2013
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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