UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031878 |
|---|---|
| Receipt number | R000035161 |
| Scientific Title | Clinical study of Mesa Biotech Flu A / Flu B Test |
| Date of disclosure of the study information | 2018/03/24 |
| Last modified on | 2019/03/27 16:44:01 |
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Basic information
Public title
Clinical study of Mesa Biotech Flu A / Flu B Test
Acronym
Clinical study of Mesa Biotech Flu A / Flu B Test
Scientific Title
Clinical study of Mesa Biotech Flu A / Flu B Test
Scientific Title:Acronym
Clinical study of Mesa Biotech Flu A / Flu B Test
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation of Mesa Biotech Flu A / Flu B Test
Basic objectives2
Others
Basic objectives -Others
Sensitivity of the early stage
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time before becoming positive from the onset
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Collection of the specimen
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
| 16 | years-old | < |
Age-upper limit
| 110 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All out-patients with flu-like symptoms
Key exclusion criteria
out-patients without agreement in this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Endo |
Organization
Internal University of Health and Welfare Shioya Hospital
Division name
Infection control unit
Zip code
3292145
Address
77 Tomita Yaita City
TEL
0287-44-1155
ain@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shiro |
| Middle name | |
| Last name | Endo |
Organization
Internal University of Health and Welfare Shioya Hospital
Division name
Infection control unit
Zip code
3292145
Address
77 Tomita Yaita City
TEL
0287-44-1155
Homepage URL
ain@iuhw.ac.jp
Sponsor or person
Institute
Internal University of Health and Welfare Shioya Hospital
Institute
Department
Personal name
Funding Source
Organization
KYOKUTO PHARMACEUTICAL INDUSTRIAL 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
Internal University of Health and Welfare
Address
3, 537, Iguti, Nasushiobara City, Tochigi
Tel
0287-37-2221
masa-takahashi@iuhw.ac.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
| 2018 | Year | 03 | Month | 24 | 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
168
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
| 2018 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035161
