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

September 24, 2015 updated by: GlaxoSmithKline

Population Based Surveillance 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

552

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

  • Spain
      • Barcelona, Spain, 08034
        • GSK Investigational Site
      • Madrid, Spain, 28037
        • GSK Investigational Site
      • Valencia, Spain, 46020
        • GSK Investigational Site
      • Valencia, Spain, 46021
        • 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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult population, male or female, ≥50 years of age presenting with a HZ episode.

Description

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.

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
Group A
Subjects presenting with HZ episode.
Other: Data collection
HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
up to one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of PHN, i.e. persistence of HZ-related pain.
Time Frame: 90, 180, and 270 days after onset of HZ.
90, 180, and 270 days after onset of HZ.
Anamnestic information, clinical parameters and complications related to HZ.
Time Frame: Between Day 0 and Day 270
Between Day 0 and Day 270
Direct medical, direct non-medical and indirect costs related to HZ.
Time Frame: Between Day 0 and Day 90
Between Day 0 and Day 90
Pain assessment in HZ subjects.
Time Frame: At Day 90
At Day 90
Quality of life assessment in HZ subjects
Time Frame: Day 15, Day 30, Day 60 and Day 90
Day 15, Day 30, Day 60 and Day 90
Direct medical, direct non-medical and indirect costs related to PHN.
Time Frame: At Day 90, Day 180 and Day 270
At Day 90, Day 180 and Day 270
Pain assessment in PHN subjects.
Time Frame: At Day 90, Day 180 and Day 270
At Day 90, Day 180 and Day 270
Quality of life assessment in PHN subjects.
Time Frame: At Day 90, Day 180 and Day 270
At Day 90, Day 180 and 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

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114617

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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