Clinical trial NCT01521286: Study to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
Official title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Postherpetic Neuralgia in Spain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Keywords: Spain
cost
complications
incidence
adults
quality of life
Herpes Zoster
Surveillance
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 552
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population, male or female, ≥50 years of age presenting with a HZ episode.

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)


Eligibility 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.

Primary outcomes:
measure: Total number of HZ cases as recorded per participating practice, overall and within a specific age group and gender.
timeFrame: up to one year
Secondary outcomes:
measure: Occurrence of PHN, i.e. persistence of HZ-related pain.
timeFrame: 90, 180, and 270 days after onset of HZ.
measure: Anamnestic information, clinical parameters and complications related to HZ.
timeFrame: Between Day 0 and Day 270
measure: Direct medical, direct non-medical and indirect costs related to HZ.
timeFrame: Between Day 0 and Day 90
measure: Pain assessment in HZ subjects.
timeFrame: At Day 90
measure: Quality of life assessment in HZ subjects
timeFrame: Day 15, Day 30, Day 60 and Day 90
measure: Direct medical, direct non-medical and indirect costs related to PHN.
timeFrame: At Day 90, Day 180 and Day 270
measure: Pain assessment in PHN subjects.
timeFrame: At Day 90, Day 180 and Day 270
measure: Quality of life assessment in PHN subjects.
timeFrame: At Day 90, Day 180 and Day 270
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.