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

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ClinicalTrials.gov Identifier: NCT01772160
Recruitment Status : Completed
First Posted : January 21, 2013
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment
Herpes Zoster Other: Data collection

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.


Study Type : Observational
Actual Enrollment : 395 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Population Based Surveillance to Estimate the Burden of Herpes Zoster and Post-herpetic Neuralgia in Italy
Actual Study Start Date : February 26, 2013
Actual Primary Completion Date : October 5, 2016
Actual Study Completion Date : October 5, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. Occurrence of PHN, i.e. persistence of HZ-related pain. [ Time Frame: Days 90, 180, and 270 after onset of HZ. ]
  2. Anamnestic information, clinical parameters and complications related to HZ. [ Time Frame: Between Day 0 and Day 270. ]
  3. Direct medical, direct non-medical and indirect costs related to HZ. [ Time Frame: Between Day 0 and Day 270. ]
  4. Pain assessment in HZ patients. [ Time Frame: At Day 90. ]
  5. Quality of life assessment in HZ patients. [ Time Frame: At Day 15, Day 30, Day 60 and Day 90. ]
  6. Direct medical, direct non-medical and indirect costs related to PHN. [ Time Frame: At Day 90, Day 180 and Day 270. ]
  7. Pain assessment in PHN patients. [ Time Frame: At Day 90, Day 180 and Day 270. ]
  8. Quality of life assessment in PHN patients. [ Time Frame: At Day 90, Day 180 and Day 270. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01772160


  Show 59 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01772160     History of Changes
Other Study ID Numbers: 116208
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017

Keywords provided by GlaxoSmithKline:
Adults
Italy
Herpes Zoster
Complications
Quality of life
Surveillance
Burden
Cost
Incidence

Additional relevant MeSH terms:
Neuralgia
Herpes Zoster
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases