Last updated: 09/03/2019 12:10:07
Burden of Herpes zoster and post-herpetic neuralgia among people ≥ 50 years old in France
GSK study ID
201926
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Burden of Herpes zoster and post-herpetic neuralgia among people ≥ 50 years old in France: the POSTHER study
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) related direct medical costs by drugs prescribed
Timeframe: 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
Timeframe: At Inclusion (Month 0)
Evaluation of HZ and PHN related direct and indirect medical costs by drugs prescribed, sick leave prescription and medical visits
Timeframe: 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
Timeframe: 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
Timeframe: From Month 6 to Month 9
Secondary outcomes:
Evaluation of HZ and PHN severity for last 24 hour worst pain from the ZBPI questionnaire
Timeframe: 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
Timeframe: At inclusion (Month 0), Month 1, 3, 6 and 9
Evaluation of impact of HZ and PHN on quality of life and utilities using EQ-5D-5L questionnarie
Timeframe: At inclusion (Month 0)
Evaluation of impact of HZ and PHN on quality of life and utilities using EQ-5D-5L for PHN Cohort
Timeframe: At inclusion (Month 0), Month 1, 3, 6 and 9
Interventions:
Other: Data collection
Enrollment:
106
Observational study model:
Cohort
Primary completion date:
2017-28-08
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
January 2016 to August 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50+ years
Accepts healthy volunteers
No
- 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,
- None
Inclusion and exclusion criteria
Inclusion criteria:
- 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,
- 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”.
For HZ cohort
Able to understand the study, to complete self-administered questionnaires and to answer phone interviews.
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2017-28-08
Actual study completion date
2017-28-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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