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

NCT ID: NCT01521286

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-05-31

Brief Summary

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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)

Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group A

Subjects presenting with HZ episode.

Data collection

Intervention Type OTHER

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

Interventions

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Data collection

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

GSK Investigational Site

Valencia, , Spain

Site Status

Countries

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Spain

References

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Diez-Domingo J, Curran D, Cambronero MDR, Garcia-Martinez JA, Matthews S. Economic Burden and Impact on Quality of Life of Herpes Zoster in Spanish Adults Aged 50 Years or Older: A Prospective Cohort Study. Adv Ther. 2021 Jun;38(6):3325-3341. doi: 10.1007/s12325-021-01717-7. Epub 2021 May 19.

Reference Type DERIVED
PMID: 34013498 (View on PubMed)

Other Identifiers

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114617

Identifier Type: -

Identifier Source: org_study_id

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