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


Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name