Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France

NCT02487472 | Completed Results

• 1 other identifier: 201926
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the burden of Herpes zoster (HZ) and post-herpetic neuralgia (PHN) among people ≥ 50 years old in France, in terms of healthcare resources used, medical direct and indirect costs, as well as pain severity and impact on quality of life.

Conditions

Herpes Zoster

Keywords

France; Post-herpetic neuralgia; Herpes zoster; Economic burden of disease

Outcome Measures

Primary Outcomes (5)

• Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.

  Evaluation of HZ and PHN related direct medical costs were done by the drugs prescribed before and at inclusion. The drugs prescribed were defined as a direct cost.

  Before inclusion and at inclusion (Month 0)

• Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit

  Evaluation of HZ and PHN related indirect costs, estimated by direct medical costs were done by the sick leave prescription and medical visit at inclusion. Sick leave prescriptions were defined as an indirect medical cost and medical visits were defined as a direct medical cost.

  At Inclusion (Month 0)

• Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits

  Evaluation of HZ and PHN related direct medical costs were done by drugs prescribed, sick leaves prescribed, medical visits to a specialist and patient reference to a hospital.

  Cumulatively up to Month 3

• Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits

  Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 3 to month 6 for the PHN cohort

  From Month 3 to Month 6

• Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits

  Evaluation of HZ and PHN related direct and indirect medical costs were done by the drugs prescribed, sick leaves prescribed and medical visits from month 6 to month 9 for the PHN cohort

  From Month 6 to Month 9

Secondary Outcomes (4)

• Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire

  At inclusion (Month 0), Month 1 and Month 3

• Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire

  At inclusion (Month 0), Month 1, 3, 6 and 9

• Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie

  At inclusion (Month 0)

• Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort

  At inclusion (Month 0), Month 1, 3, 6 and 9

Study Arms (1)

HZ cohort

All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and no earlier case of HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved.

Other: Data collection

Interventions

Data collection OTHER

Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

HZ cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study has been designed to include 250 patients ≥ 50 years old with a first visit for diagnosis of HZ during a 6-month inclusion period (HZ cohort) and 40 expected cases of PHN after 3 months of HZ rash onset.

You may qualify if:

• For HZ cohort
• Patient with a first visit for a diagnosis of HZ and who attend the clinic within two week of the HZ start of symptoms,
• Without history of previous HZ,
• ≥ 50 years old,
• Who agree to participate and signed informed consent,
• Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.
• For PHN cohort
• All Patients of the HZ cohort presenting PHN 3 months after onset of the HZ rash onset will be included in the PHN cohort. PHN will be defined as the presence of HZ-associated severe pains: ≥ 3 of the ZBPI item "worst pain".

You may not qualify if:

• None

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Herpes Zoster; Neuralgia, Postherpetic

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

lzr30020@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 1, 2015
• Study Start: January 19, 2016
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: September 4, 2019
• Results First Posted: September 4, 2019

Record last verified: 2019-08