Unique ID issued by UMIN | UMIN000012670 |
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Receipt number | R000014720 |
Scientific Title | The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2. |
Date of disclosure of the study information | 2013/12/24 |
Last modified on | 2019/01/30 13:42:51 |
The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.
The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.
The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.
The Clinical and Virology effects of NA inhibitor in influenza virus infections (age;over 4 years old, under 13 years old):an open-label,randomized study Part 2.
Japan |
Childfood influenza infections
Medicine in general | Pediatrics |
Others
NO
To evaluate the clinical and virology effects of NA inhibitor on influenza virus (Sub-types;A/H1N1pdm2009,A/H3N2)and safty in childhood .
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
-Time to virus disappeared from the start of drug administration
-Time to return to normal body temperature (under 37.5 degrees)
-Time of flu symptoms to disappear
-The amount of change per unit time of the virus titer to the last observation time and day 3
-The drug sensitivity change for each NA inhibitor
-The time course and antibody titer
-Rate of relapse
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
Central registration
4
Treatment
Medicine |
Oseltamivir
Zanamivir
Peramivir
Laninamivir
4 | years-old | <= |
13 | years-old | > |
Male and Female
1) Age:over 4 years old, under 13 years old.
2) Patients or Guardian of the patients with informd consent.
3) Out Patient of febrile symptom.
4) The patient who consulted within 48 hours of fever with over 37.5 degrees.
5) A rapid antigen test of Influenza is positive (type A).
1)History of hypersensitivity caused by neuraminidase inhibitors.
2)Patients with (high risk factors) underlying disease that is estimated to affect the course of virus.
3)Patients were deemed inappropriate for the study participants.
160
1st name | |
Middle name | |
Last name | Nobuo Hirotsu |
Hirotsu Clinic
Internal Medicine, Pediatrics
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
044-822-1933
non-hirotsu@umin.ac.jp
1st name | |
Middle name | |
Last name | Nobuo Hirotsu |
Hirotsu Clinic
Internal Medicine, Pediatrics
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki-shi, Kanagawa-ken, 231-0011, Japan
044-822-1933
non-hirotsu@umin.ac.jp
Hirotsu Clinic
SHIONOGI&CO.,LTD.
Profit organization
Japan
SHIONOGI&CO.,LTD.
NO
廣津医院(神奈川県)
渡辺クリニック(神奈川県)
2013 | Year | 12 | Month | 24 | Day |
Partially published
http://www.tandfonline.com/doi/pdf/10.1080/14787210.2018.1421945?needAccess=true
1st half of the study result (virus dynamics)were shown below:
http://www.tandfonline.com/doi/pdf/10.1080/14787210.2018.1421945?needAccess=true
2nd half of the study result (antibody dynamics) has been submitted (under review)
Completed
2013 | Year | 12 | Month | 09 | Day |
2013 | Year | 12 | Month | 17 | Day |
2015 | Year | 03 | Month | 28 | Day |
2015 | Year | 05 | Month | 11 | Day |
2015 | Year | 12 | Month | 10 | Day |
2013 | Year | 12 | Month | 24 | Day |
2019 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014720
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