UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030136 |
|---|---|
| Receipt number | R000034411 |
| Scientific Title | In vitro neuraminidase inhibitory concentration of four neuraminidase inhibitors and their clinical efficacy |
| Date of disclosure of the study information | 2017/11/28 |
| Last modified on | 2018/08/23 15:34:56 |
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Basic information
Public title
In vitro neuraminidase inhibitory concentration of four neuraminidase inhibitors and their clinical efficacy
Acronym
Survey for virus resistance and clinical efficacy of four NA inhibitors
Scientific Title
In vitro neuraminidase inhibitory concentration of four neuraminidase inhibitors and their clinical efficacy
Scientific Title:Acronym
Survey for virus resistance and clinical efficacy of four NA inhibitors
Region
| Japan |
Condition
Condition
Influenza
Classification by specialty
| Medicine in general | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
IC50 of influenza virus and clinical efficacy
Basic objectives2
Others
Basic objectives -Others
IC50
Duration of fever
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
IC50
Duration of fever
Key secondary outcomes
Base
Study type
Observational
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
Influenza diagnosed with an influenza antigen detection kit
Key exclusion criteria
N/A
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Kawai |
Organization
Kawai Clinic
Division name
Medicine in general
Zip code
Address
4-32 Kanazono-cho Gifu-shi, Gifu, 500-8113
TEL
058-245-0564
nkawai@city.gifu.med.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chigusa Iwasaki |
Organization
RICERCA CLINICA Co.,Ltd
Division name
Clinical support center
Zip code
Address
2-18-30 Yaesuhakata Bld.6F, Hakataeki Higashi, Hakata-ku, Fukuoka-shi, Fukuoka 812-0013
TEL
092-435-1150
Homepage URL
secretary@ricercaclinica.jp
Sponsor or person
Institute
Japan Physicians Association
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
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
Address
Tel
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
| 2017 | Year | 11 | Month | 28 | 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
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2018 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 08 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
IC50
Duration of fever
Management information
Registered date
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034411
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
