Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01772160
Recruitment Status : Completed
First Posted : January 21, 2013
Results First Posted : May 22, 2020
Last Update Posted : May 22, 2020
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 Herpes Zoster Vaccine 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.

Layout table for study information
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
Herpes Zoster Group
Male or female subjects aged 50 years or above, presenting with a herpes zoster (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. Overall Incidence Rate of Herpes Zoster (HZ) Cases, by Age and Gender [ Time Frame: Day 0 to 2 years ]
    A case of HZ was defined as new unilateral pain (broadly defined to include allodynia and pruritus) accompanied by unilateral rash and no alternative diagnosis. Age ranges were 50-54, 55-59, 60-64, 65-69, 70-74, 75-79 and greater than or equal to (≥) 80 years. The incidence rate was expressed as the number of HZ cases per (/) 1000 person-years.


Secondary Outcome Measures :
  1. Percentage of Postherpetic Neuralgia (PHN) Cases Among HZ, Overall [ Time Frame: At Day 90, 180 and 270 after onset of HZ ]
    PHN persistence refers to pain occurring or persisting from Day 90 to Day 270 after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.

  2. General Medical History of Cases With HZ, Overall [ Time Frame: Between Day 0 and Day 270. ]
    General medical history focused on characteristics such as patient pre-existing condition and diseases (local trauma, diabetes mellitus, liver disease, alcoholism, renal failure/dialysis, emotional problems, stress or depression, blood malignancy, solid malignancy, hematopoetic cell/ bone marrow transplant, solid organ transplantation, HIV infection, hepatitis C under active therapy, autoimmune disease active and under therapy, other).

  3. Other General Medical History Characteristics for HZ Cases, Overall [ Time Frame: Between Day 0 and Day 270. ]
    Other general medical history characteristics referred to arterial problems, cerebral problems, gastric problems, gastric problems, prostate problems (arterial hypertension and allergic rhinitis, arterial hypertension and pacemaker, arteriopathy and past nun-Hodgkin lymphoma, atrial fibrillation, bronchopathy, cerebral thrombosis, cholecyst, chronic cerebral ischemia, chronic leukemia, chronic obstructive pulmonary disease, epilepsy, gastric lymphoma, gastropathy, hypertension, hypertension and hypothyroidism after surgery, hypertension dyslipidemia and hyperthyroidism, hypothyroidism hypertension, polycythaemia, polycythaemia from 10 years, prostate neoplasm, prostate oral anticoagulant therapy cardiopathy, prostatic cancer, right feet arthralgia, thrombocytopenia, vasculopathy chronic brain).

  4. Clinical Information of Cases With HZ, Overall [ Time Frame: Between Day 0 and Day 270 ]
    Clinical information of HZ cases referred to experience of any symptoms before rash, actual symptoms before rash (SBR), any complications at initial visit.

  5. Complications Related to HZ Cases, Overall [ Time Frame: Between Day 0 and Day 270 ]
    HZ related complications refer to cutaneous complications (Varicella Zoster Virus [VZV] dissemination, Bacterial superinfection), ocular (Loss of corneal sensation, Keratitis, Scleritis, Uveitis, Iridocyclitis), neurological (Meningo-encephalitis, Cranial nerve palsies, Peripheral nerve palsies, Ramsay-Hunt syndrome, Persistent HZ-related Pain), visceral [Neural extension of VZV infection (bronchitis, esophagitis,cystitis), VZV dissemination (pneumonia, arthritis, hepatitis] and other.

  6. Other Complications Related to HZ Cases, Overall [ Time Frame: Between Day 0 and Day 270 ]
    HZ related other complications refer to axillary lympagenopathy, burning sensation, hypoacusis, itching and rectum pain.

  7. Direct Medical Costs, Direct Non-medical Costs and Indirect Costs [ Time Frame: Up to Day 90 ]
    Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.

  8. Worst Pain Assessment in HZ Subjects [ Time Frame: At Day 90 ]
    The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.

  9. Average Pain Assessment in HZ Subjects [ Time Frame: At Day 90 ]
    The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.

  10. Impact of HZ on Quality of Life as Assessed by the Zoster Pain Inventory [ Time Frame: At Day 0, 15, 30, 60, 90 ]
    PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.

  11. Impact of HZ on Quality of Life as Assessed by the EuroQoL-Five Digits [ Time Frame: At Day 0, 15, 30, 60, 90 ]
    EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index/scale goes from 0 (worst health state) to 1 (perfect health state).

  12. PHN Direct Medical Costs, Direct Non-medical Costs and Indirect Costs by Payer/Societal Perspective [ Time Frame: Between Day 90 and Day 270 ]
    Cost data related to HZ included medication, procedures and referral to hospital/specialist for direct medical costs, transport for direct non-medical costs and missed time from work, sick certificate for the indirect costs.

  13. Worst Pain Assessment in PHN Subjects [ Time Frame: At Day 90 ]
    The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. the ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.

  14. Average Pain Assessment in PHN Subjects [ Time Frame: At Day 90 ]
    The ZBPI is an assessment tool in the form of a questionnaire completed by the patient that is specifically designed to assess HZ-associated pain and discomfort. The ZBPI includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'. Note: The Day 90 window included assessments between Day 83 and Day 97 relative to day of rash onset.

  15. Impact of PHN on Quality of Life as Assessed by the Zoster Pain Inventory [ Time Frame: At Day 0, 15, 30, 60, 90 ]
    PHN persistence refers to pain occurring or persisting between 90-270 days after the rash onset. PHN was assessed via the Zoster Pain Inventory (ZBPI) questionnaire, which includes four pain severity items (worst, least, average, present pain) and seven pain interference items which assess general activity, mood, walking ability, work, relations with others, sleep and enjoyment of life. All of the items are rated on an 11-point Likert scale (0-10). For the severity items, 0 = 'no pain' and 10 = 'pain as bad as you can imagine', whereas for the interference items, 0 = 'does not interfere' and 10 = 'completely interferes'.

  16. Impact of PHN on Quality of Life as Assessed by the EuroQoL-Five Digits [ Time Frame: At Day 0, 15, 30, 60, 90 ]
    EuroQoL-Five Digits (EQ-5D) is a standardised instrument for use as a measure of health outcome and is designed for self-completion by respondents. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 1 (best health state).



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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


Locations
Layout table for location information
Italy
GSK Investigational Site
Napoli, Campania, Italy, 80125
GSK Investigational Site
Napoli, Campania, Italy, 80126
GSK Investigational Site
Roma, Lazio, Italy, 00141
GSK Investigational Site
Roma, Lazio, Italy, 00142
GSK Investigational Site
Roma, Lazio, Italy, 00144
GSK Investigational Site
Roma, Lazio, Italy, 00162
GSK Investigational Site
Roma, Lazio, Italy, 00176
GSK Investigational Site
Roma, Lazio, Italy, 00197
GSK Investigational Site
Angera (VA), Lombardia, Italy
GSK Investigational Site
Arcisate (VA), Lombardia, Italy, 21051
GSK Investigational Site
Comerio (VA), Lombardia, Italy, 21020
GSK Investigational Site
Fagnano Olona (VA), Lombardia, Italy, 21054
GSK Investigational Site
Ghirla Valganna (VA), Lombardia, Italy, 21030
GSK Investigational Site
Induno Olona (VA), Lombardia, Italy, 21040
GSK Investigational Site
Sesto Calende (VA), Lombardia, Italy, 21018
GSK Investigational Site
Solbiate Olona (VA), Lombardia, Italy, 21052
GSK Investigational Site
Varese, Lombardia, Italy, 21100
GSK Investigational Site
Alessandria, Piemonte, Italy, 15121
GSK Investigational Site
Frugarolo (AL), Piemonte, Italy, 15065
GSK Investigational Site
Oviglio (AL), Piemonte, Italy, 15026
GSK Investigational Site
Sale (AL), Piemonte, Italy, 15045
GSK Investigational Site
Villalvernia (AL), Piemonte, Italy, 15050
GSK Investigational Site
Cavallino (LE), Puglia, Italy, 73020
GSK Investigational Site
Copertino (LE), Puglia, Italy, 73043
GSK Investigational Site
Cutrofiano (LE), Puglia, Italy, 73020
GSK Investigational Site
Galatina (LE), Puglia, Italy, 73013
GSK Investigational Site
Montesano S. (LE), Puglia, Italy, 73035
GSK Investigational Site
Parabita (LE), Puglia, Italy, 73052
GSK Investigational Site
Specchia (LE), Puglia, Italy, 73040
GSK Investigational Site
Arcidosso (GR), Toscana, Italy, 58031
GSK Investigational Site
Arezzo, Toscana, Italy, 52100
GSK Investigational Site
Civitella Paganico (GR), Toscana, Italy, 58045
GSK Investigational Site
Follonica (GR), Toscana, Italy, 58022
GSK Investigational Site
Grosseto, Toscana, Italy, 58100
GSK Investigational Site
Lucignano (AR), Toscana, Italy, 52046
GSK Investigational Site
Orbetello (GR), Toscana, Italy, 58015
GSK Investigational Site
Sassofortino (GR), Toscana, Italy, 58029
GSK Investigational Site
Perugia, Umbria, Italy, 06125
GSK Investigational Site
Perugia, Umbria, Italy, 06126
GSK Investigational Site
Perugia, Umbria, Italy
GSK Investigational Site
Ripa (PG), Umbria, Italy, 06134
GSK Investigational Site
Alessano (LE), Italy
GSK Investigational Site
Rome, Italy, 00144
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Publications:
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01772160    
Other Study ID Numbers: 116208
First Posted: January 21, 2013    Key Record Dates
Results First Posted: May 22, 2020
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=20346
Keywords provided by GlaxoSmithKline:
Adults
Italy
Herpes Zoster
Complications
Quality of life
Surveillance
Burden
Cost
Incidence
Additional relevant MeSH terms:
Layout table for MeSH terms
Herpes Zoster
Neuralgia
Neuralgia, Postherpetic
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Varicella Zoster Virus Infection