Last updated: 07/18/2020 12:10:50

Study to estimate the burden of herpes zoster (HZ) and post-herpetic neuralgia (PHN) in Italy

GSK study ID
116208
See study documents
Clinicaltrials.gov ID
NCT01772160
See results summary
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 post-herpetic neuralgia in Italy
Trial description: The purpose of this study is to collect data on the incidence, complications, economic burden and impact on the quality of life in adults aged ≥ 50 years with HZ disease in Italy.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Overall incidence rate of Herpes Zoster (HZ) cases, by age and gender

Timeframe: Day 0 to 2 years

Secondary outcomes:

Percentage of Postherpetic Neuralgia (PHN) cases among HZ, overall

Timeframe: At Day 90, 180 and 270 after onset of HZ

General medical history of cases with HZ, overall

Timeframe: Between Day 0 and Day 270.

Other general medical history characteristics for HZ cases, overall

Timeframe: Between Day 0 and Day 270.

Clinical information of cases with HZ, overall

Timeframe: Between Day 0 and Day 270

Complications related to HZ cases, overall

Timeframe: Between Day 0 and Day 270

Other complications related to HZ cases, overall

Timeframe: Between Day 0 and Day 270

Direct medical costs, direct non-medical costs and indirect costs

Timeframe: Up to Day 90

Worst pain assessment in HZ subjects

Timeframe: At Day 90

Average pain assessment in HZ subjects

Timeframe: At Day 90

Impact of HZ on quality of life as assessed by the Zoster Pain Inventory

Timeframe: At Day 0, 15, 30, 60, 90

Impact of HZ on quality of life as assessed by the EuroQoL-Five Digits

Timeframe: At Day 0, 15, 30, 60, 90

PHN direct medical costs, direct non-medical costs and indirect costs by payer/societal perspective

Timeframe: Between Day 90 and Day 270

Worst pain assessment in PHN subjects

Timeframe: At Day 90

Average pain assessment in PHN subjects

Timeframe: At Day 90

Impact of PHN on quality of life as assessed by the Zoster Pain Inventory

Timeframe: At Day 0, 15, 30, 60, 90

Impact of PHN on quality of life as assessed by the EuroQoL-Five Digits

Timeframe: At Day 0, 15, 30, 60, 90

Interventions:
  • Other: Data collection
    • Enrollment:
    395
    Primary completion date:
    2016-05-10
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Salvetti A et al. (2019) Incidence of herpes zoster and postherpetic neuralgia in Italian adults aged ≥50 years: A prospective study. Prev Med Rep. 14:100882.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    February 2013 to October 2016
    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:
    • Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).
    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 his/her first outpatient diagnosis (i.e. initial consultation), OR

      • Took place at another site/centre (e.g. emergency room or Dermatologist/Specialist practice) provided the HZ diagnosis is not more than 7 days before the initial visit for the present study (i.e. secondary consultation).

      • Written informed consent obtained from the patient.
      • Ability to comply with study procedures.
    Exclusion criteria:

      Patient participating in another clinical study (participation in another observational, non-interventional trial is allowed).

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Alessandria, Piemonte, Italy, 15121
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alessano (LE), Italy
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Angera (VA), Lombardia, Italy
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arcidosso (GR), Toscana, Italy, 58031
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arcisate (VA), Lombardia, Italy, 21051
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arezzo, Toscana, Italy, 52100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cavallino (LE), Puglia, Italy, 73020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Civitella Paganico (GR), Toscana, Italy, 58045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Comerio (VA), Lombardia, Italy, 21020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Copertino (LE), Puglia, Italy, 73043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cutrofiano (LE), Puglia, Italy, 73020
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fagnano Olona (VA), Lombardia, Italy, 21054
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Follonica (GR), Toscana, Italy, 58022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Frugarolo (AL), Piemonte, Italy, 15065
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Galatina (LE), Puglia, Italy, 73013
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ghirla Valganna (VA), Lombardia, Italy, 21030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Grosseto, Toscana, Italy, 58100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Induno Olona (VA), Lombardia, Italy, 21040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lucignano (AR), Toscana, Italy, 52046
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Montesano S. (LE), Puglia, Italy, 73035
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Napoli, Campania, Italy, 80125
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Napoli, Campania, Italy, 80126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orbetello (GR), Toscana, Italy, 58015
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oviglio (AL), Piemonte, Italy, 15026
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Parabita (LE), Puglia, Italy, 73052
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Perugia, Umbria, Italy
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Perugia, Umbria, Italy, 06125
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Perugia, Umbria, Italy, 06126
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ripa (PG), Umbria, Italy, 06134
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00142
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00144
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00162
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00176
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Roma, Lazio, Italy, 00197
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rome, Italy, 00144
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sale (AL), Piemonte, Italy, 15045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sassofortino (GR), Toscana, Italy, 58029
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sesto Calende (VA), Lombardia, Italy, 21018
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Solbiate Olona (VA), Lombardia, Italy, 21052
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Specchia (LE), Puglia, Italy, 73040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Varese, Lombardia, Italy, 21100
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Villalvernia (AL), Piemonte, Italy, 15050
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    No study documents available

    Recruitment status
    Study complete
    Actual primary completion date
    2016-05-10
    Actual study completion date
    2016-05-10

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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