UMIN-CTR Clinical Trial

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	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	1021
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	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	2020 Year 12 Month 27 Day
Date trial data considered complete	2021 Year 04 Month 20 Day
Date analysis concluded	2021 Year 07 Month 25 Day

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

Management information
Registered date	2019 Year 02 Month 19 Day
Last modified on	2022 Year 06 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040936