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
Study complete
Study complete
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:
Enrollment:
106
Primary completion date:
2017-28-08
Observational study model:
Cohort
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)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
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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