![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
![]() |
Name | UMIN ID |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000048518 |
Receipt No. | R000054847 |
Scientific Title | Estimation of preference for selection of oral COVID-19 treatments |
Date of disclosure of the study information | 2022/08/02 |
Last modified on | 2022/07/29 |
Basic information | ||
Public title | Estimation of preference for selection of oral COVID-19 treatments | |
Acronym | Estimation of preference for selection of oral COVID-19 treatments | |
Scientific Title | Estimation of preference for selection of oral COVID-19 treatments | |
Scientific Title:Acronym | Estimation of preference for selection of oral COVID-19 treatments | |
Region |
|
Condition | ||
Condition | COVID-19 | |
Classification by specialty |
|
|
Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To estimate the economic value of S-217622, an oral COVID-19 treatment that is under application for approval, by investigating factors associated with the preference of treatment and differences in the preference by attributes and background of the respondents. |
Basic objectives2 | Others |
Basic objectives -Others | preference |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Preference of factors about the oral COVID-19 treatments: dosage form and size, frequency of administration per day, number of drugs at once, number of days taking not to infect others from initiation of the treatment, developed company (domestic or foreign company), and out-of-pocket cost |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | 1. General population: 10,000 people
2. People who have been infected with SARS-CoV-2: 1,000 people: 1,000 people (if the number of respondents does not reach the target number, those between 10 and 79 years old will be included). |
|||
Key exclusion criteria | People who stop responding to the survey (not considered as respondents) | |||
Target sample size | 11000 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Shionogi & Co., Ltd. | ||||||
Division name | Medical Affairs Dept. | ||||||
Zip code | 541-0045 | ||||||
Address | 3-1-8, Doshomachi, Chuo-ku, Osaka | ||||||
TEL | 06-6209-7412 | ||||||
shinzo.hiroi@shionogi.co.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Shionogi & Co., Ltd. | ||||||
Division name | Medical Affairs Dept. | ||||||
Zip code | 541-0045 | ||||||
Address | 3-1-8, Doshomachi, Chuo-ku, Osaka | ||||||
TEL | 06-6209-7412 | ||||||
Homepage URL | |||||||
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 |
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 |
|
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 | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
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 people in a research panel in a research company.
The results of the survey will be analyzed using conjoint analysis. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054847 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |