N/A
N=101
Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT02487472 ↗Enrolled (actual)
101
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. — 10; 1; 3; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Data collection (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. |
10; 1; 3; 0; 4; 1 | — |
| PRIMARY Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit |
3; 1; 9; 1; 6; 0 | — |
| PRIMARY Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire |
0; 0; 0; 1; 0; 3 | — |
| SECONDARY Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire |
0; 0; 0; 1; 0; 3 | — |
| SECONDARY Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie |
0.67; 0.72; 68.38; 73.13 | — |
| SECONDARY Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort |
0.70; 0.09; -0.02; 0.17; 0.16; 77.50 | — |
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.
Eligibility Criteria
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
- None
Data sourced from ClinicalTrials.gov (NCT02487472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.