Unique ID issued by UMIN | UMIN000010024 |
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Receipt number | R000011738 |
Scientific Title | The clinical and Virology effects of NA inhibitor in influenza virus infections (age; over 4 years old, under 11 years old): an open-label, randomized study. |
Date of disclosure of the study information | 2013/02/14 |
Last modified on | 2013/12/16 09:29:10 |
The clinical and Virology effects of NA inhibitor in influenza virus infections (age; over 4 years old, under 11 years old): an open-label, randomized study.
The clinical and Virology effects of NA inhibitor in influenza virus infections (age; over 4 years old, under 11 years old): an open-label, randomized study.
The clinical and Virology effects of NA inhibitor in influenza virus infections (age; over 4 years old, under 11 years old): an open-label, randomized study.
The clinical and Virology effects of NA inhibitor in influenza virus infections (age; over 4 years old, under 11 years old): an open-label, randomized study.
Japan |
Childhood influenza infections
Medicine in general | Pediatrics |
Others
NO
To evaluate the clinical and virology effects of NA inhibitor on influenza virus (Sub-types; A/H1N1pdm09, A/H3N2) in Childhood.
Efficacy
Confirmatory
Pragmatic
Not applicable
-Time to return to normal body temperature (under 37.5 degrees)
-Influenza virus titer (TCID50)
-Duration of influenza symptoms patients
-IC50 in NA inhibition assays of NA inhibitors
-Virus mutation after treatment of NA inhibitors
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
4
Treatment
Medicine |
Oseltamivir
Zanamivir
Peramivir
Laninamivir
4 | years-old | <= |
11 | years-old | > |
Male and Female
1)Age: over 4 years old, under 11 years old.
2)Guardian of the patients with informed 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).
History of hypersensitivity caused by neuraminidase inhibitors. Patients who are deemed to be inappropriate by the investigator.
120
1st name | |
Middle name | |
Last name | Nobuo Hirotsu |
Hirotsu Clinic
Internal Medicine, Pediatrics
Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki, 231-0011, Japan
044-822-1933
1st name | |
Middle name | |
Last name |
Hirotsu Clinic
Internal Medicine, Pediatrics
044-822-1933
Hirotsu Clinic
SHIONOGI & CO., LTD.
Profit organization
Japan
SHIONOGI & CO., LTD.
NO
廣津医院(神奈川県)
2013 | Year | 02 | Month | 14 | Day |
Published
Completed
2013 | Year | 01 | Month | 20 | Day |
2013 | Year | 01 | Month | 21 | Day |
2013 | Year | 06 | Month | 01 | Day |
2013 | Year | 02 | Month | 13 | Day |
2013 | Year | 12 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011738
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