Overview

This trial is active, not recruiting.

Condition herpes zoster
Treatment data collection
Sponsor GlaxoSmithKline
Start date January 2016
End date April 2017
Trial size 250 participants
Trial identifier NCT02487472, 201926

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
data collection
Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire
All patients of the HZ cohort presenting PHN 3 months after HZ rash onset symptoms will be included secondarily in the PHN cohort.
data collection
Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire

Primary Outcomes

Measure
HZ-related direct medical costs and indirect costs
time frame: At Month 0
HZ-related direct medical costs and indirect costs
time frame: At Month 1
HZ-related direct medical costs and indirect costs
time frame: At Month 3
PHN-related direct medical costs and indirect costs
time frame: At Month 0
PHN-related direct medical costs and indirect costs
time frame: At Month 1
PHN-related direct medical costs and indirect costs
time frame: At Month 3
PHN-related direct medical costs and indirect costs
time frame: At Month 6
PHN-related direct medical costs and indirect costs
time frame: At Month 9

Secondary Outcomes

Measure
HZ severity
time frame: At Months 0, 1 and 3
Quality of life and utilities in HZ cohort
time frame: At Months 0, 1 and 3
PHN severity
time frame: At Months 0, 1, 3, 6 and 9
Quality of life and utilities in PHN cohort
time frame: At Months 0, 1, 3, 6 and 9

Eligibility Criteria

Male or female participants at least 50 years old.

Inclusion Criteria: - 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". Exclusion Criteria:

Additional Information

Official title Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study
Description - An observational, prospective cohort study of patients ≥ 50 years old with a Herpes Zoster (HZ) diagnosis, carried out by a national random sample of community first line practitioners concerned by HZ diagnosis: general practitioners, dermatologists and ophthalmologists. - All patients ≥ 50 years old with a HZ diagnosis (as the primary diagnoses and without history of previous HZ) during approximately 6 months inclusion period will be included in the HZ cohort, until total study target is achieved. - All Patients of the HZ cohort presenting a Post-herpetic neuralgia (PHN) 3 months after onset of the HZ rash onset will be included secondarily in the PHN cohort - Patients of the HZ cohort will be followed-up for 3 months (i.e. 1 and 3 months after HZ rash onset) and patients of the PHN cohort will be followed-up for additional 6 months (i.e., 6 and 9 months after HZ rash onset) using phone interviews with a nurse. - 250 cases of HZ and 40 cases of PHN are expected, with the hypothesis of 16% of PHN 3 months after HZ rash onset.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.