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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02487472
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Herpes Zoster
Intervention Other: Data collection
Enrollment 106
Recruitment Details Inclusion timeframe for the study was initially planned for 6 months. Due to the low rate of inclusion, this timeframe was extended from 6 to 13.5 months. A total of 106 subjects from the Herpes Zoster (HZ) cohort were included in this study.
Pre-assignment Details Out of 106 subjects included,5 subjects were excluded due to the following reasons:<50 years,previous history of HZ ,not the first visit,consulted physician more than 2 weeks after start of HZ symptoms. A total of 101 subjects were included for analysis.Out of the 101 subjects,90 subjects completed the study.
Arm/Group Title HZ Cohort
Hide Arm/Group Description All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
Period Title: Overall Study
Started 101
Completed 90
Not Completed 11
Reason Not Completed
Did not complete telephonic interviews             9
Other             2
Arm/Group Title HZ Cohort
Hide Arm/Group Description All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
Overall Number of Baseline Participants 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 101 participants
68.1  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 101 participants
Female
56
  55.4%
Male
45
  44.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Evaluation of Herpes Zoster (HZ) and Postherpetic Neuralgia (PHN) Related Direct Medical Costs by Drugs Prescribed.
Hide Description 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.
Time Frame Before inclusion and at inclusion (Month 0)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HZ Cohort PHN Cohort
Hide Arm/Group Description:
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 101 8
Measure Type: Count of Participants
Unit of Measure: Participants
Antalgic-antipyretic, before inclusion
10
   9.9%
1
  12.5%
NSAIDs, before inclusion
3
   3.0%
0
   0.0%
Systemic direct acting antiviral, before inclusion
4
   4.0%
1
  12.5%
Direct acting antiviral, at inclusion
89
  88.1%
6
  75.0%
Direct acting antiviral- systemic, at inclusion
89
  88.1%
6
  75.0%
Local cutaneous, at inclusion
11
  10.9%
2
  25.0%
Direct acting antiviral-Local ophthalmic-inclusion
1
   1.0%
0
   0.0%
At least one Antalgic
53
  52.5%
6
  75.0%
Antalgic Level I
27
  26.7%
3
  37.5%
Antalgic Level II
24
  23.8%
3
  37.5%
2.Primary Outcome
Title Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Sick Leave Prescription and Medical Visit
Hide Description 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.
Time Frame At Inclusion (Month 0)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HZ Cohort PHN Cohort
Hide Arm/Group Description:
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 101 8
Measure Type: Count of Participants
Unit of Measure: Participants
Sick leave prescription
3
   3.0%
1
  12.5%
Medical visit, Patient referred to a specialist
9
   8.9%
1
  12.5%
Medical visit, Ophtalmologist
6
   5.9%
0
   0.0%
Medical visit, Dermatologist
3
   3.0%
1
  12.5%
Medical visit, Angiologist
1
   1.0%
0
   0.0%
Medical visit, Patient referred to the hospital
1
   1.0%
1
  12.5%
3.Primary Outcome
Title Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Hide Description 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.
Time Frame Cumulatively up to Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HZ Cohort PHN Cohort
Hide Arm/Group Description:
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 90 6
Measure Type: Count of Participants
Unit of Measure: Participants
Drugs prescribed, Systemic
80
  88.9%
4
  66.7%
Drugs prescribed, Local
12
  13.3%
2
  33.3%
Drugs prescribed, Antalgic Level I
34
  37.8%
6
 100.0%
Drugs prescribed, Antalgic Level II
20
  22.2%
3
  50.0%
Sick leave prescription
5
   5.6%
1
  16.7%
Medical visit, General practitioner
89
  98.9%
6
 100.0%
Medical visit, Dermatologist
6
   6.7%
0
   0.0%
Medical visit, Ophthalmologist
2
   2.2%
0
   0.0%
Medical visit, Magnetizer
20
  22.2%
3
  50.0%
Medical visit, Acupuncturist
3
   3.3%
0
   0.0%
Medical visit, Healer
2
   2.2%
0
   0.0%
Medical visit, Osteopath
1
   1.1%
0
   0.0%
Medical visit, Radiologist
1
   1.1%
0
   0.0%
Medical visit, Rheumatologist
1
   1.1%
0
   0.0%
4.Primary Outcome
Title Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Hide Description 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
Time Frame From Month 3 to Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title PHN Cohort
Hide Arm/Group Description:
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Drugs prescribed, direct acting antiviral,Systemic
0
   0.0%
Drugs prescribed, direct acting antiviral,Local
0
   0.0%
Drugs prescribed, Antalgic Level I
1
  16.7%
Drugs prescribed, Antalgic Level II
0
   0.0%
Sick leave prescription
0
   0.0%
Medical visits, Visits
3
  50.0%
Medical visits, General practitioner
0
   0.0%
Medical visits, Dermatologist
0
   0.0%
Medical visits, Ophthalmologist
0
   0.0%
Medical visits, Magnetizer
0
   0.0%
Medical visits, Acupuncturist
0
   0.0%
5.Primary Outcome
Title Evaluation of HZ and PHN Related Direct and Indirect Medical Costs by Drugs Prescribed, Sick Leave Prescription and Medical Visits
Hide Description 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
Time Frame From Month 6 to Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title PHN Cohort
Hide Arm/Group Description:
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Drugs prescribed, direct acting antiviral,Systemic
0
   0.0%
Drugs prescribed, direct acting antiviral,Local
0
   0.0%
Drugs prescribed, Antalgic Level I
0
   0.0%
Drugs prescribed, Antalgic Level II
0
   0.0%
Sick leave prescription
1
  16.7%
Medical visits, Visits
0
   0.0%
Medical visits, General practitioner
0
   0.0%
Medical visits, Dermatologist
0
   0.0%
Medical visits, Ophthalmologist
0
   0.0%
Medical visits, Magnetizer
0
   0.0%
Medical visits, Acupuncturist
0
   0.0%
6.Secondary Outcome
Title Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Hide Description

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.
Time Frame At inclusion (Month 0), Month 1 and Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HZ Cohort
Hide Arm/Group Description:
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
Overall Number of Participants Analyzed 101
Measure Type: Count of Participants
Unit of Measure: Participants
Mild pain (1-2), Month 0
7
   6.9%
Mild Pain (1-2), Month 1
7
   6.9%
Mild Pain (1-2), Month 3
10
   9.9%
Moderate pain (3-6), Month 0
42
  41.6%
Moderate pain (3-6), Month 1
23
  22.8%
Moderate pain (3-6), Month 3
5
   5.0%
Severe pain (7-10), Month 0
45
  44.6%
Severe pain (7-10), Month 1
12
  11.9%
Severe pain (7-10), Month 3
3
   3.0%
7.Secondary Outcome
Title Evaluation of HZ and PHN Severity for Last 24 Hour Worst Pain From the ZBPI Questionnaire
Hide Description 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.
Time Frame At inclusion (Month 0), Month 1, 3, 6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title PHN Cohort
Hide Arm/Group Description:
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Mild pain (1-2), Month 0 Number Analyzed 8 participants
0
   0.0%
Mild pain (1-2), Month 1 Number Analyzed 6 participants
0
   0.0%
Mild pain (1-2), Month 3 Number Analyzed 8 participants
0
   0.0%
Mild pain (1-2), Month 6 Number Analyzed 8 participants
1
  12.5%
Mild pain (1-2), Month 9 Number Analyzed 8 participants
0
   0.0%
Moderate pain (3-6), Month 0 Number Analyzed 8 participants
3
  37.5%
Moderate pain (3-6), Month 1 Number Analyzed 6 participants
4
  66.7%
Moderate pain (3-6), Month 3 Number Analyzed 8 participants
5
  62.5%
Moderate pain (3-6), Month 6 Number Analyzed 8 participants
1
  12.5%
Moderate pain (3-6), Month 9 Number Analyzed 8 participants
0
   0.0%
Severe pain (7-10), Month 0 Number Analyzed 8 participants
5
  62.5%
Severe pain (7-10), Month 1 Number Analyzed 6 participants
2
  33.3%
Severe pain (7-10), Month 3 Number Analyzed 8 participants
3
  37.5%
Severe pain (7-10), Month 6 Number Analyzed 8 participants
2
  25.0%
Severe pain (7-10), Month 9 Number Analyzed 8 participants
2
  25.0%
8.Secondary Outcome
Title Evaluation of Impact of HZ and PHN on Quality of Life (QOL) and Utilities Using EQ-5D-5L Questionnarie
Hide Description

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

Time Frame At inclusion (Month 0)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title HZ Cohort PHN Cohort
Hide Arm/Group Description:
All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 101 8
Mean (Standard Deviation)
Unit of Measure: Quality of life score
EQ-5D-5L index value 0.67  (0.28) 0.72  (0.19)
EQ-VAS health state 68.38  (19.13) 73.13  (12.80)
9.Secondary Outcome
Title Evaluation of Impact of HZ and PHN on Quality of Life and Utilities Using EQ-5D-5L for PHN Cohort
Hide Description

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

Time Frame At inclusion (Month 0), Month 1, 3, 6 and 9
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title PHN Cohort
Hide Arm/Group Description:
All subjects from the HZ cohort, who reported PHN at 3 months were included in the PHN sub cohort and were followed up for 6 more months (up to 9 months from inclusion).
Overall Number of Participants Analyzed 8
Median (Inter-Quartile Range)
Unit of Measure: Quality of life score
EQ-5D-5L index value, Month 0 Number Analyzed 8 participants
0.70
(0.40 to 1.00)
EQ-5D-5L index value, Month 1 Number Analyzed 6 participants
0.09
(-0.51 to 0.26)
EQ-5D-5L index value, Month 3 Number Analyzed 8 participants
-0.02
(-0.22 to 0.51)
EQ-5D-5L index value, Month 6 Number Analyzed 8 participants
0.17
(0.00 to 0.40)
EQ-5D-5L index value, Month 9 Number Analyzed 8 participants
0.16
(0.00 to 0.37)
EQ-VAS health state, Month 0 Number Analyzed 8 participants
77.50
(50.00 to 90.00)
EQ-VAS health state, Month 1 Number Analyzed 6 participants
-5.0
(-50.00 to 20.00)
EQ-VAS health state, Month 3 Number Analyzed 8 participants
-10.0
(-30.00 to 10.00)
EQ-VAS health state, Month 6 Number Analyzed 8 participants
5.0
(-30.00 to 24.00)
EQ-VAS health state, Month 9 Number Analyzed 8 participants
0
(-30.00 to 24.00)
Time Frame No adverse events data were collected.
Adverse Event Reporting Description No adverse events data were collected
 
Arm/Group Title HZ Cohort
Hide Arm/Group Description All subjects ≥ 50 years old with an HZ diagnosis as the primary diagnosis during the inclusion period were included in the HZ cohort and followed up for 3 months from inclusion (month 0).
All-Cause Mortality
HZ Cohort
Affected / at Risk (%)
Total   0/0 
Hide Serious Adverse Events
HZ Cohort
Affected / at Risk (%)
Total   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HZ Cohort
Affected / at Risk (%)
Total   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: lzr30020@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02487472    
Other Study ID Numbers: 201926
First Submitted: June 25, 2015
First Posted: July 1, 2015
Results First Submitted: January 9, 2019
Results First Posted: September 4, 2019
Last Update Posted: September 4, 2019