NCT01521286

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 30, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 28, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

January 26, 2012

Last Update Submit

September 24, 2015

Conditions

Herpes Zoster

Keywords

Spaincostcomplicationsincidenceadultsquality of lifeHerpes ZosterSurveillance

Outcome Measures

Primary Outcomes (1)

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

    up to one year

Secondary Outcomes (8)

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

    90, 180, and 270 days after onset of HZ.

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

    Between Day 0 and Day 270

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

    Between Day 0 and Day 90

  • Pain assessment in HZ subjects.

    At Day 90

  • Quality of life assessment in HZ subjects

    Day 15, Day 30, Day 60 and Day 90

  • +3 more secondary outcomes

Study Arms (1)

Group A

Subjects presenting with HZ episode.

Other: Data collection

Interventions

Data collectionOTHER

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

Group A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Barcelona, 08034, Spain

Location

GSK Investigational Site

Madrid, 28037, Spain

Location

GSK Investigational Site

Valencia, 46020, Spain

Location

GSK Investigational Site

Valencia, 46021, Spain

Location

Related Publications (1)

  • 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.

    PMID: 34013498DERIVED

MeSH Terms

Conditions

Herpes Zoster

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus InfectionHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 30, 2012

Study Start

March 1, 2012

Primary Completion

November 1, 2014

Study Completion

May 1, 2015

Last Updated

September 28, 2015

Record last verified: 2015-09

Locations

ES(4)