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

This study is currently recruiting participants.
Verified April 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01521286
First received: January 26, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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)


Condition Intervention
Herpes Zoster Vaccine
 Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of PHN, i.e. persistence of HZ-related pain. [ Time Frame: 90, 180, and 270 days after onset of HZ. ] [ Designated as safety issue: No ]
  • Anamnestic information, clinical parameters and complications related to HZ. [ Time Frame: Between Day 0 and Day 270 ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to HZ. [ Time Frame: Between Day 0 and Day 90 ] [ Designated as safety issue: No ]
  • Pain assessment in HZ subjects. [ Time Frame: At Day 90 ] [ Designated as safety issue: No ]
  • Quality of life assessment in HZ subjects [ Time Frame: Day 15, Day 30, Day 60 and Day 90 ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to PHN. [ Time Frame: At Day 90, Day 180 and Day 270 ] [ Designated as safety issue: No ]
  • Pain assessment in PHN subjects. [ Time Frame: At Day 90, Day 180 and Day 270 ] [ Designated as safety issue: No ]
  • Quality of life assessment in PHN subjects. [ Time Frame: At Day 90, Day 180 and Day 270 ] [ Designated as safety issue: No ]

Estimated Enrollment: 539
Study Start Date: March 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group A
Subjects presenting with HZ episode.
 Other: Data collection
HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521286

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Spain
GSK Investigational Site Recruiting
Madrid, Spain, 28037
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
GSK Investigational Site Recruiting
Valencia, Spain, 46021
Contact: US GSK Clinical Trials Call Center     877-379-3718     GSKClinicalSupportHD@gsk.com    
Contact: EU GSK Clinical Trials Call Center     +44 (0) 20 8990 4466     GSKClinicalSupportHD@gsk.com    
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01521286     History of Changes
Other Study ID Numbers: 114617
Study First Received: January 26, 2012
Last Updated: April 5, 2013
Health Authority: Spain: Agencia Espanola de Medicamentos y Productos Sanitarios

Keywords provided by GlaxoSmithKline:
incidence
cost
adults
Surveillance
 quality of life
Spain
complications
Herpes Zoster

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013