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
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2016-05-10
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).

Trial location(s)

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

Study documents

Protocol
Available language(s): English

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

Results overview

No study documents available

Recruitment status
Finalized
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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