UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041452 |
|---|---|
| Receipt number | R000046899 |
| Scientific Title | Estimation of cost value based on the convenience of an anti-influenza agent baloxavir marboxil |
| Date of disclosure of the study information | 2020/08/18 |
| Last modified on | 2022/02/22 16:16:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Estimation of cost value based on the convenience of an anti-influenza agent baloxavir marboxil
Acronym
Estimation of cost value based on the convenience of an anti-influenza agent baloxavir marboxil
Scientific Title
Estimation of cost value based on the convenience of an anti-influenza agent baloxavir marboxil
Scientific Title:Acronym
Estimation of cost value based on the convenience of an 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 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, frequency, and duration of administration, and out-of-pocket expenses
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
| 20 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who were prescribed any influenza drugs (oral or inhalation) last season (from October 2018 to April 2019) or this season (from October 2019 to the present)
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
shinzo.hiroi@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Yokomasu |
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
akira.yokomasu@shionogi.co.jp
Sponsor or person
Institute
Shionogi & CO., LTD.
Institute
Department
Personal name
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
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 | 08 | Month | 18 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/13696998.2021.1877150
Number of participants that the trial has enrolled
3137
Results
The monetary value for oral antivirals was estimated to be higher, saving JPY 741 (USD 7.06, as of August 2020), compared with inhalant. Regarding the length and frequency of administration, five days corresponds to an increase of JPY 2,072, compared with one day, and twice a day corresponds to a JPY 574 increase compared to once a day.
Results date posted
| 2022 | Year | 02 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 02 | Month | 12 | Day |
Baseline Characteristics
Individuals who were prescribed any influenz
a drugs (oral or inhalation) last season (fr
om October 2018 to April 2019) or this seaso
n (from October 2019 to the present)
Participant flow
We used an online panel managed by research company for the online survey. The respondents were selected by screening questions.
Adverse events
N/A
Outcome measures
Convenience of drugs: route, frequency, and
duration of administration). The values were converted as montetary values based on the utility of out-of-pocket expenses.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | 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
| 2020 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046899
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
