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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042606
Receipt No. R000048468
Scientific Title Estimation of cost value for health care professionals based on the convenience of anti-influenza agent baloxavir marboxil
Date of disclosure of the study information 2020/12/01
Last modified on 2020/12/04

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Basic information
Public title Estimation of cost value for health care professionals based on the convenience of anti-influenza agent baloxavir marboxil
Acronym Estimation of cost value for health care professionals based on the convenience of anti-influenza agent baloxavir marboxil
Scientific Title Estimation of cost value for health care professionals based on the convenience of anti-influenza agent baloxavir marboxil
Scientific Title:Acronym Estimation of cost value for health care professionals based on the convenience of anti-influenza agent baloxavir marboxil
Region
Japan

Condition
Condition influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To estimate the monetary value of convenience of an influenza drug baloxavir marboxil, which is taken orally and one time, for health care professionals, particularly considering working time and infection risk.
Basic objectives2 Others
Basic objectives -Others convenience
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Length of time and frequency of drug administration instruction/assistance.
Key secondary outcomes Whether to feel worried about infection or not and willing to pay to avoid infection risk when doing drug administration instruction/assistance.

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Physicians, pharmacists, or care workers.
Key exclusion criteria N/A
Target sample size 2750

Research contact person
Name of lead principal investigator
1st name Shinzo
Middle name
Last name Hiroi
Organization Shionogi & Co., Ltd.
Division name Medical Affairs Dept.
Zip code 530-0012
Address 1-1-4, Shibata, Kita-ku Osaka
TEL 06-6485-5201
Email shinzo.hiroi@shionogi.co.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Kurazono
Organization Shionogi & Co., Ltd.
Division name Medical Affairs Dept.
Zip code 530-0012
Address 1-1-4, Shibata, Kita-ku Osaka
TEL 06-6485-5201
Homepage URL
Email kenji.kurazono@shionogi.co.jp

Sponsor
Institute Shionogi & Co., Ltd.
Institute
Department

Funding Source
Organization Shionogi & 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 RIHDS Ethical Review Board
Address 12th Floor, Sumitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo
Tel 03-5733-5010
Email rihds@jmdc.co.jp

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
2020 Year 12 Month 01 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
2020 Year 10 Month 26 Day
Date of IRB
2020 Year 11 Month 30 Day
Anticipated trial start date
2020 Year 12 Month 01 Day
Last follow-up date
2020 Year 12 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A questionnaire survey will be performed for the eligible individuals in research panels in research companies.
The monetary value for being shorten the time of drug administration instruction/assistance will be calculated based on the answer to the length of time and frequency of drug administration instruction/assistance and average wage.

Management information
Registered date
2020 Year 12 Month 01 Day
Last modified on
2020 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048468

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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