UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005356 |
|---|---|
| Receipt number | R000006358 |
| Scientific Title | Epidemiological study on herpes zoster |
| Date of disclosure of the study information | 2011/03/31 |
| Last modified on | 2014/03/26 00:11:01 |
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Basic information
Public title
Epidemiological study on herpes zoster
Acronym
Epidemiological study on herpes zoster
Scientific Title
Epidemiological study on herpes zoster
Scientific Title:Acronym
Epidemiological study on herpes zoster
Region
| Japan |
Condition
Condition
herpes zoster
Classification by specialty
| Infectious disease | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect epidemiological findings of herpes zoster and review factors of its pathogenesis
Basic objectives2
Others
Basic objectives -Others
-The incidence of herpes zoster.
-Severity and duration of pain.
-Relationships of the incidence with lifestyle and sociopsychological factors.
-Relationships of the incidence with the state of cell-mediated immunity (CMI) and humoral immunity.
-Relationships of the cell-mediated immunity and the humoral-mediated immunity.
-Duration of CMI and humoral immunity.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
-The number of patients developed herpes zoster
-Degree of pain by 6-level face scale
-Duration of pain
-Health questionnaire of 31 items
-Level of cell-mediated immunity by varicella intradermal skin test (at baseline, 1 year later, 2 years later and 3 years later)
-Level of cell-mediated immunity by ELISPOT (at baseline, 1 year later, 2 years later, 3 years later, in onset and at the recovery)
-Level of humoral immunity by gp-ELISA, IAHA and NT (at baseline, 1 year later, 2 years later, 3 years later, in onset and at the recovery)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who meet the following requirements as of October 1st, 2008. There is no upper age limit.
Subject A : 50 or older
Subject B : 50 or older
Subject C : 60 or older
Subject C' : 60 or older
2.Those who possess Japanese citizenship and live in Shozu, Kagawa as of October 1st, 2008.
3.Those who give consent in writing to cooperate on this study.
Key exclusion criteria
Participants enrolled in Subject B, C or C' may not be accepted, if they meet the following items on the day varicella intradermal skin reaction is evaluated.
1.Those who with epidemic dermatosis.
2.Other than above, those who are not suitable for varicella intradermal skin test or blood sampling.
Some participants may not be enrolled when the organizers consider they are inappropriate even they meet the above criteria.
Target sample size
12000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Yamanishi |
Organization
National Institute of Biomedical Innovation
Division name
Director General
Zip code
Address
7-6-8 Saito Asagi Ibaraki-City Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimihiko Yoshii |
Organization
National Institute of Biomedical Innovation
Division name
Department of Strategic Planning
Zip code
Address
7-6-8 Asagi Saito Ibaraki-City Osaka
TEL
072-641-9832
Homepage URL
k-yoshii@nibio.go.jp
Sponsor or person
Institute
National Institute of Biomedical Innovation
Institute
Department
Personal name
Funding Source
Organization
Japan Health Sciences Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Research Foundation for Microbial Diseases of Osaka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 31 | Day |
Last modified on
| 2014 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006358
