UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035938 |
|---|---|
| Receipt number | 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 | 2022/06/22 17:29:31 |
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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
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
yoshitaka_ogaki@ebc-m.com
Sponsor or person
Institute
Non-Profit Organization
Health Institute Research of Skin
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040936
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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