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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044243
Receipt No. R000050134
Scientific Title Estimation of cost value of anti-influenza agents based on the convenience for parents/guardians of child patients
Date of disclosure of the study information 2021/05/18
Last modified on 2021/08/02

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Basic information
Public title Estimation of cost value of anti-influenza agents based on the convenience for parents/guardians of child patients
Acronym Estimation of cost value of anti-influenza agents based on the convenience for parents/guardians of child patients
Scientific Title Estimation of cost value of anti-influenza agents based on the convenience for parents/guardians of child patients
Scientific Title:Acronym Estimation of cost value of anti-influenza agents based on the convenience for parents/guardians of child patients
Region
Japan

Condition
Condition influenza
Classification by specialty
Infectious disease Pediatrics
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 parents or guardians of child patients, particularly considering the route and frequency of administration.
Basic objectives2 Others
Basic objectives -Others convenience
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Convenience of drugs: route and dosage form, frequency of administration, duration of administration, and costs
Key secondary outcomes

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 Patients of guardians of child patients who took oral or inhalation anti-influenza drugs at the age of 6-11 past three seasons (in 2018 or later).
Key exclusion criteria N/A
Target sample size 3000

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, Suitomo Shiba Daimon Building, 2- 5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
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
2021 Year 05 Month 18 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 Completed
Date of protocol fixation
2021 Year 04 Month 05 Day
Date of IRB
2021 Year 05 Month 17 Day
Anticipated trial start date
2021 Year 05 Month 20 Day
Last follow-up date
2021 Year 05 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 panel in a research company.
The results of survey will be analyzed by conjoint analysis.

Management information
Registered date
2021 Year 05 Month 18 Day
Last modified on
2021 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050134

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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