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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: January 17, 2013
Last updated: April 14, 2016
Last verified: March 2016
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.

Condition Intervention
Herpes Zoster
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of HZ cases as recorded per participating centre, overall and within a specific age group and gender. [ Time Frame: Day 0 to 2 years approximately. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of PHN, i.e. persistence of HZ-related pain. [ Time Frame: Days 90, 180, and 270 after onset of HZ. ] [ Designated as safety issue: No ]
  • Anamnestic information, clinical parameters and complications related to HZ. [ Time Frame: Between Day 0 and Day 270. ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to HZ. [ Time Frame: Between Day 0 and Day 270. ] [ Designated as safety issue: No ]
  • Pain assessment in HZ patients. [ Time Frame: At Day 90. ] [ Designated as safety issue: No ]
  • Quality of life assessment in HZ patients. [ Time Frame: At Day 15, Day 30, Day 60 and Day 90. ] [ Designated as safety issue: No ]
  • Direct medical, direct non-medical and indirect costs related to PHN. [ Time Frame: At Day 90, Day 180 and Day 270. ] [ Designated as safety issue: No ]
  • Pain assessment in PHN patients. [ Time Frame: At Day 90, Day 180 and Day 270. ] [ Designated as safety issue: No ]
  • Quality of life assessment in PHN patients. [ Time Frame: At Day 90, Day 180 and Day 270. ] [ Designated as safety issue: No ]

Estimated Enrollment: 409
Study Start Date: February 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HZ Group
Subjects presenting with an HZ episode.
Other: 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.

Detailed Description:

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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult population, male or female aged ≥ 50 years of age presenting with a HZ episode.

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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01772160

Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 67 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT01772160     History of Changes
Other Study ID Numbers: 116208 
Study First Received: January 17, 2013
Last Updated: April 14, 2016
Health Authority: Italy: AIFA, Ufficio Ricerca e Sperimentazione Clinica

Keywords provided by GlaxoSmithKline:
Herpes Zoster
Quality of life

Additional relevant MeSH terms:
Herpes Zoster
Neuralgia, Postherpetic
DNA Virus Infections
Herpesviridae Infections
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms
Virus Diseases processed this record on May 26, 2016