UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002675 |
|---|---|
| Receipt number | R000002975 |
| Scientific Title | Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection |
| Date of disclosure of the study information | 2009/10/29 |
| Last modified on | 2015/10/27 09:03:10 |
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Basic information
Public title
Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection
Acronym
Study on the treatment of Novel influenza
Scientific Title
Study on effectiveness of treatment against influenza like illness(ILI) and swine origin influenza A (H1N1) virus infection
Scientific Title:Acronym
Study on the treatment of Novel influenza
Region
| Japan |
Condition
Condition
Influenza like illness (ILI) and Swine origin influenza A(H1N1) virus infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The ideal treatment strategy of swine origin influenza A(H1N1) virus infection is unknown.
This study evaluate the effectiveness of this virus infection and ILI, making hospitalization and mortality on day 7 as primary outcome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hospitalization and mortality on day 7
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oseltamivir
Interventions/Control_2
zanamivir
Interventions/Control_3
Mao-to
Interventions/Control_4
acetaminophen
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
no underlying health condition
Key exclusion criteria
needs hospitalization
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwata |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
Kusunoki-cho 7-5-1, Chuo-ku, Kobe
TEL
0783826296
kiwata@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Iwata |
Organization
Kobe University
Division name
Division of Infectious Diseases
Zip code
Address
Kusunokicho 7-5-2, Chuoku, Kobe
TEL
0783826296
Homepage URL
kentaroiwata1969@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 10 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 27 | Day |
Last modified on
| 2015 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002975
