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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035938
Receipt No. R000040936
Scientific Title Epidemiologic survey about zoster-associated pain and PHN in herpes zoster patients after antiherpesvirus drug treatment.
Date of disclosure of the study information 2019/02/19
Last modified on 2019/08/21

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Basic information
Public title Epidemiologic survey about zoster-associated pain and PHN in herpes zoster patients after antiherpesvirus drug treatment.
Acronym pain residual rate survey
Scientific Title Epidemiologic survey about zoster-associated pain and PHN in herpes zoster patients after antiherpesvirus drug treatment.
Scientific Title:Acronym pain residual rate survey
Region
Japan

Condition
Condition herpes zoster
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to investigate the herpes zoster-associated pain and PHN residual rate in the patients who was prescribed amenamevir Tab for herpes zoster, using an evaluation of the initial pain and a convalescence questionnaire.
Basic objectives2 Others
Basic objectives -Others Observational
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Until disappearance of zoster-associated pain pass, and change time for 12M.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) The patient of herpes zoster, and was prescribed amenamevir Tab.
2) Written informed consent
3) Age >=20 at informed consent
Key exclusion criteria The patient who has the complications that cannot judge a pain due to the herpes zoster exactly.(For example, dementia, lumbago, others)
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Makoto
Middle name
Last name Kawashima
Organization Non-Profit Organization
Health Institute Research of Skin
Division name vice chief director
Zip code 101-0047
Address FukudaBilding 2F,1-8-9 Uchikanda, Chiyoda-ku, Tokyo
TEL 03-3256-2575
Email kawashima.makoto@twmu.ac.jp

Public contact
Name of contact person
1st name Yoshitaka
Middle name
Last name Ogaki
Organization EBC&M LLC.
Division name Clinical Business Department
Zip code 105-0011
Address 2-9-1 Shibakoen Minato-ku, Tokyo
TEL 03-6435-3833
Homepage URL
Email yoshitaka_ogaki@ebc-m.com

Sponsor
Institute Non-Profit Organization
Health Institute Research of Skin
Institute
Department

Funding Source
Organization Maruho Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Non-Profit Organization Health Institute Research of Skin Ethics Review Board
Address FukudaBilding 2F,1-8-9 Uchikanda, Chiyoda-ku, Tokyo
Tel 0332562575
Email info@npo-hifu.net

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
2019 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 25 Day
Date of IRB
2019 Year 02 Month 15 Day
Anticipated trial start date
2019 Year 02 Month 26 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Questionary survey at-home for 12 months

Management information
Registered date
2019 Year 02 Month 19 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040936

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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