Last updated: 06/01/2022 04:10:07

Study to estimate the burden of herpes zoster and postherpetic neuralgia in Spain

GSK study ID
114617
Clinicaltrials.gov ID
NCT01521286
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Population based surveillance to estimate the burden of herpes zoster and postherpetic neuralgia in Spain
Trial description: 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)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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:

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

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

Anamnestic information, clinical parameters and complications related to HZ.

Timeframe: Between Day 0 and Day 270

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

Timeframe: Between Day 0 and Day 90

Pain assessment in HZ subjects.

Timeframe: At Day 90

Quality of life assessment in HZ subjects

Timeframe: Day 15, Day 30, Day 60 and Day 90

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

Timeframe: At Day 90, Day 180 and Day 270

Pain assessment in PHN subjects.

Timeframe: At Day 90, Day 180 and Day 270

Quality of life assessment in PHN subjects.

Timeframe: At Day 90, Day 180 and Day 270

Interventions:
  • Other: Data collection
    • Enrollment:
    552
    Primary completion date:
    2014-25-11
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Garcia Comas L, Cerdan T, Cambronero MDR, Garcia Martinez JA, Lopez Sanroma M, Gopala K, Simone B, Diez-Domingo J. Incidence of herpes zoster and its complications in ≥50-year-old Spanish adults: a prospective cohort study. Vacunas. 2022; DOI: http://dx.doi.org/ 10.1016/j.vacun.2022.01.006
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to May 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    50+ years
    Accepts healthy volunteers
    No
    • A male or female >=50 years of age at the time of study enrolment presenting with acute HZ;
    • HZ diagnosis for this HZ episode;
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Madrid, Spain, 28037
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valencia, Spain, 46021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Barcelona, Spain, 08034
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Valencia, Spain, 46020
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2014-25-11
    Actual study completion date
    2015-29-05

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website