Study to Estimate the Burden of Herpes Zoster (HZ) and Post-herpetic Neuralgia (PHN) in Italy

NCT ID: NCT01772160

Last Updated: 2020-05-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

395 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-26

Study Completion Date

2016-10-05

Brief Summary

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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.

Detailed Description

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The surveillance/recruitment period will take approximately 2 years and once the enrolment of HZ patients has ended, the study will continue for a maximum of 9 months to allow for completion of the follow-up of potential PHN cases.

The data will be captured at protocol specified time-points based on the time of enrolment of each subject.

Conditions

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Herpes Zoster Herpes Zoster Vaccine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Herpes Zoster Group

Male or female subjects aged 50 years or above, presenting with a herpes zoster (HZ) episode.

Data collection

Intervention Type OTHER

HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.

Interventions

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Data collection

HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Cavallino (LE), Apulia, Italy

Site Status

GSK Investigational Site

Copertino (LE), Apulia, Italy

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GSK Investigational Site

Cutrofiano (LE), Apulia, Italy

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GSK Investigational Site

Galatina (LE), Apulia, Italy

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GSK Investigational Site

Montesano S. (LE), Apulia, Italy

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GSK Investigational Site

Parabita (LE), Apulia, Italy

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GSK Investigational Site

Specchia (LE), Apulia, Italy

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GSK Investigational Site

Napoli, Campania, Italy

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Napoli, Campania, Italy

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Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Rome, Lazio, Italy

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GSK Investigational Site

Angera (VA), Lombardy, Italy

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GSK Investigational Site

Arcisate (VA), Lombardy, Italy

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GSK Investigational Site

Comerio (VA), Lombardy, Italy

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GSK Investigational Site

Fagnano Olona (VA), Lombardy, Italy

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GSK Investigational Site

Ghirla Valganna (VA), Lombardy, Italy

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GSK Investigational Site

Induno Olona (VA), Lombardy, Italy

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GSK Investigational Site

Sesto Calende (VA), Lombardy, Italy

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GSK Investigational Site

Solbiate Olona (VA), Lombardy, Italy

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GSK Investigational Site

Varese, Lombardy, Italy

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GSK Investigational Site

Alessandria, Piedmont, Italy

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GSK Investigational Site

Frugarolo (AL), Piedmont, Italy

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GSK Investigational Site

Oviglio (AL), Piedmont, Italy

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GSK Investigational Site

Sale (AL), Piedmont, Italy

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GSK Investigational Site

Villalvernia (AL), Piedmont, Italy

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GSK Investigational Site

Arcidosso (GR), Tuscany, Italy

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GSK Investigational Site

Arezzo, Tuscany, Italy

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GSK Investigational Site

Civitella Paganico (GR), Tuscany, Italy

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GSK Investigational Site

Follonica (GR), Tuscany, Italy

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GSK Investigational Site

Grosseto, Tuscany, Italy

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GSK Investigational Site

Lucignano (AR), Tuscany, Italy

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GSK Investigational Site

Orbetello (GR), Tuscany, Italy

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GSK Investigational Site

Sassofortino (GR), Tuscany, Italy

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GSK Investigational Site

Perugia, Umbria, Italy

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GSK Investigational Site

Perugia, Umbria, Italy

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GSK Investigational Site

Perugia, Umbria, Italy

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GSK Investigational Site

Ripa (PG), Umbria, Italy

Site Status

GSK Investigational Site

Alessano (LE), , Italy

Site Status

GSK Investigational Site

Rome, , Italy

Site Status

Countries

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Italy

References

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Salvetti A, Ferrari V, Garofalo R, Gazzaniga P, Guerroni A, Metrucci A, Sessa A, Severi ML, Nati G, Ruggeri M, Rossi A, Cappellari L, Gopala K, Tosatto R, Simone B. Incidence of herpes zoster and postherpetic neuralgia in Italian adults aged >/=50 years: A prospective study. Prev Med Rep. 2019 Apr 24;14:100882. doi: 10.1016/j.pmedr.2019.100882. eCollection 2019 Jun.

Reference Type BACKGROUND
PMID: 31193254 (View on PubMed)

Matthews S, De Maria A, Passamonti M, Ristori G, Loiacono I, Puggina A, Curran D. The Economic Burden and Impact on Quality of Life of Herpes Zoster and Postherpetic Neuralgia in Individuals Aged 50 Years or Older in Italy. Open Forum Infect Dis. 2019 Jan 12;6(2):ofz007. doi: 10.1093/ofid/ofz007. eCollection 2019 Feb.

Reference Type DERIVED
PMID: 30793003 (View on PubMed)

Other Identifiers

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116208

Identifier Type: -

Identifier Source: org_study_id

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