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NCT Number: NCT01521286

Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

The purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (HZ) disease in adults >=50 years of age in Spain. This study will also collect data on costs related to the HZ disease, especially postherpetic neuralgia (PHN)

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A male or female >=50 years of age at the time of study enrolment presenting with acute HZ;
  • HZ diagnosis for this HZ episode;
  • is the subject's first outpatient diagnosis; OR
  • took place at another site/ centre up to seven days before the initial visit for the present study;
  • Ability to comply with study procedures*;
  • Written informed consent obtained from the subject*. Note: * will be applicable to secondary objectives only and not for the primary objective to calculate incidence.

Exclusion criteria

  • Subject participating in another research study. Note: This exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.

Treatment and study plan

Data Collection

Other

HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.

Primary outcomes

  1. Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.

    Time frame: up to one year

Secondary outcomes

  1. Occurrence of PHN, i.e. persistence of HZ-related pain.

    Time frame: 90, 180, and 270 days after onset of HZ.

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

    Time frame: Between Day 0 and Day 270

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

    Time frame: Between Day 0 and Day 90

  4. Pain assessment in HZ subjects.

    Time frame: At Day 90

  5. Quality of life assessment in HZ subjects

    Time frame: Day 15, Day 30, Day 60 and Day 90

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

    Time frame: At Day 90, Day 180 and Day 270

  7. Pain assessment in PHN subjects.

    Time frame: At Day 90, Day 180 and Day 270

  8. Quality of life assessment in PHN subjects.

    Time frame: At Day 90, Day 180 and Day 270

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 30, 2012
Registry last updated
Sep 28, 2015

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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