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

Herpes Zoster Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01521286
• Other study ID #: 114617
• Status: Completed
• Phase: N/A
• First received: January 26, 2012
• Last updated: September 24, 2015
• Start date: March 2012
• Est. completion date: May 2015

Study information

• Verified date: September 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: May 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Zoster
• Neuralgia, Postherpetic

Intervention

Other:
• Data collection
HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.		up to one year	No
Secondary	Occurrence of PHN, i.e. persistence of HZ-related pain.		90, 180, and 270 days after onset of HZ.	No
Secondary	Anamnestic information, clinical parameters and complications related to HZ.		Between Day 0 and Day 270	No
Secondary	Direct medical, direct non-medical and indirect costs related to HZ.		Between Day 0 and Day 90	No
Secondary	Pain assessment in HZ subjects.		At Day 90	No
Secondary	Quality of life assessment in HZ subjects		Day 15, Day 30, Day 60 and Day 90	No
Secondary	Direct medical, direct non-medical and indirect costs related to PHN.		At Day 90, Day 180 and Day 270	No
Secondary	Pain assessment in PHN subjects.		At Day 90, Day 180 and Day 270	No
Secondary	Quality of life assessment in PHN subjects.		At Day 90, Day 180 and Day 270	No