UMIN-CTR Clinical Trial

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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