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

Completed

• Conditions: Herpes Zoster
• Interventions: Other: Data collection

• Registration Number: NCT01521286
• Lead Sponsor: GlaxoSmithKline

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-01-30
• Study Start: 2012-03
• Primary Completion: 2014-11
• Study Completion: 2015-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-24
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 552

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Data collection	Subjects presenting with HZ episode.

Primary Outcome Measures

Name	Time	Method
Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.	up to one year

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GSK Investigational Site; 🇪🇸 Valencia, Spain