Herpes ZosterNCT02487472

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

An observational study of Herpes Zoster, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Herpes Zoster
What is being tested?: Data collection
How many people: 106 participants
Where: No sites listed yet
Study dates: 19 Jan 2016to 28 Aug 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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".

Who cannot join

None

About this study

Official title: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study

Read the detailed 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.

Conditions: Herpes Zoster
Being tested: Data collection
Keywords: France, Post-herpetic neuralgia, Herpes zoster, Economic burden of disease
Medical subject headings: Herpes Zoster, Neuralgia, Postherpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02487472
Study group	Role	What they receive
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. Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.
The Zoster Brief Pain Inventory (ZBPI) questionnaire is a self-administered form to assess HZ pain and burden associated with HZ pain using scales from:
- 0 for no pain to 10 for the most horrible pain that can be imagined,
- 0 for no improvement to 100% for full improvement with painkiller,
- 0 for no burden to 10 for full burden.
Measured: 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
HZ and PHN severity was evaluated using 3 categories- mild pain (0<pain<3), moderate pain (3 ≤ pain < 7) and severe pain (7 ≤ pain) for the last 24 hour worst pain.
Measured: 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
Impact of HZ \& PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system \& EQ Visual analogue scale(EQ-VAS).
EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort \& anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single mean index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A mean of this health state was recorded for subjects analyzed in this outcome measure
Measured: At inclusion (Month 0)
Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort
Impact of HZ \& PHN on QOL was evaluated using EQ-5D-5L questionnaire,which has 2 parts: EQ-5D-5L descriptive system \& EQ Visual analogue scale(EQ-VAS).
EQ-5D-5L descriptive system comprises of 5 dimensions-mobility,self-care,usual activities,pain/discomfort \& anxiety/depression.Each dimension has 5 levels:not at all(level 1),mild(level 2),moderate(level 3),severe(level 4),extreme/leading to incapacity(level 5),with highest level corresponding to worst outcome.Subjects had to indicate their health state by choosing the appropriate level from each dimension.The 5 digit health states thus obtained for each dimension were then converted into a single median index value using the EQ-5D-5L crosswalk index value calculator as recommended by EuroQol group.In the EQ-VAS,subjects had to record their health state on a scale ranging from 0(worst imaginable health state) to 100(best imaginable health state).A median of this health state was recorded for subjects analyzed in this outcome measure
Measured: At inclusion (Month 0), Month 1, 3, 6 and 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jan 201628 Aug 2017

First posted1 Jul 2015 (estimated)
Study start19 Jan 2016
Primary completion28 Aug 2017
Study completion28 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02487472
Sponsor's protocol ID: 201926
Status last verified: Aug 2019
First submitted: 25 Jun 2015
Last updated: 4 Sep 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Burden of Herpes Zoster and Post-herpetic Neuralgia Among People ≥ 50 Years Old in France: the POSTHER Study
ClinicalTrials.gov ID: NCT02487472
Acronym / sponsor ID: 201926
Conditions: Herpes Zoster
Keywords: France, Post-herpetic neuralgia, Herpes zoster, Economic burden of disease
Study type: Observational
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Jan 2016 (actual)
Primary completion: 28 Aug 2017 (actual)
Study completion: 28 Aug 2017 (actual)
First posted: 1 Jul 2015 (estimated)
Results: Posted 4 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed 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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
HZ cohort	–	Other: Data collectionAll 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

For HZ cohort
For PHN cohort

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Data collectionData sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire	Other	HZ cohort

Primary outcome

Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Time frame: Before inclusion and at inclusion (Month 0)
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.
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Time frame: At Inclusion (Month 0)
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.
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Time frame: Cumulatively up to Month 3
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.
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Time frame: From Month 3 to Month 6
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
Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Time frame: From Month 6 to Month 9
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

4 secondary outcomes

Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Time frame: 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
Time frame: 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
Time frame: At inclusion (Month 0)
Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort
Time frame: At inclusion (Month 0), Month 1, 3, 6 and 9

Results and safety

Results posted to the registry on 4 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HZ Cohort	101	90

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

Time frame: Before inclusion and at inclusion (Month 0). Count of participants. Unit: Participants

Measure	HZ Cohort n = 101	PHN Cohort n = 8
Antalgic-antipyretic, before inclusion	10	1
NSAIDs, before inclusion	3	0
Systemic direct acting antiviral, before inclusion	4	1
Direct acting antiviral, at inclusion	89	6
Direct acting antiviral- systemic, at inclusion	89	6
Local cutaneous, at inclusion	11	2
Direct acting antiviral-Local ophthalmic-inclusion	1	0
At least one Antalgic	53	6

Population analysed: The analysis was performed on subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

Primary outcome: Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit

Time frame: At Inclusion (Month 0). Count of participants. Unit: Participants

Measure	HZ Cohort n = 101	PHN Cohort n = 8
Sick leave prescription	3	1
Medical visit, Patient referred to a specialist	9	1
Medical visit, Ophtalmologist	6	0
Medical visit, Dermatologist	3	1
Medical visit, Angiologist	1	0
Medical visit, Patient referred to the hospital	1	1

Population analysed: The analysis was performed on the subjects who were diagnosed with HZ, complied with inclusion criteria and on subjects belonging to a sub-cohort (PHN cohort) from HZ cohort, diagnosed with PHN at 3 months and followed up for 6 more months.

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

Time frame: Cumulatively up to Month 3. Count of participants. Unit: Participants

Measure	HZ Cohort n = 90	PHN Cohort n = 6
Drugs prescribed, Systemic	80	4
Drugs prescribed, Local	12	2
Drugs prescribed, Antalgic Level I	34	6
Drugs prescribed, Antalgic Level II	20	3
Sick leave prescription	5	1
Medical visit, General practitioner	89	6
Medical visit, Dermatologist	6	0
Medical visit, Ophthalmologist	2	0

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

Time frame: From Month 3 to Month 6. Count of participants. Unit: Participants

Measure	PHN Cohort n = 6
Drugs prescribed, direct acting antiviral,Systemic	0
Drugs prescribed, direct acting antiviral,Local	0
Drugs prescribed, Antalgic Level I	1
Drugs prescribed, Antalgic Level II	0
Sick leave prescription	0
Medical visits, Visits	3
Medical visits, General practitioner	0
Medical visits, Dermatologist	0

Population analysed: Analysis was performed on subjects diagnosed with HZ who complied with inclusion criteria \& on subjects belonging to PHN sub-cohort from HZ cohort, diagnosed with PHN at 3 months \& followed up for 6 more months. This endpoint is presented separately for PHN cohort due to difference in timeframe for HZ cohort (0-3 months),PHN cohort (3-9 months).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse events data were collected.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HZ Cohort	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Herpes Zoster

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

Questions about this trial

What is this clinical trial studying?

An observational study of Herpes Zoster, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed. (time frame: Before inclusion and at inclusion (Month 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02487472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2019.