Unique ID issued by UMIN | UMIN000035028 |
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Receipt number | R000039927 |
Scientific Title | Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study |
Date of disclosure of the study information | 2018/11/27 |
Last modified on | 2020/05/10 14:16:18 |
Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Japan |
Influenza
Infectious disease | Pediatrics |
Others
NO
To compare Baloxavir marboxil, Oseltamivir and Laninamivir with efficacy and safety in pediatric patients with influenza.
Safety,Efficacy
The time to resolution of fever
The number of days absent from school or preschool
The number of asthmatic symptoms
The number of pneumonia
The number of gastrointestinal symptoms
The number of abnormal behaviors
Drug adherence
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
3
Treatment
Medicine |
Baloxavir marboxil
Oseltamivir
Laninamivir
Not applicable |
15 | years-old | >= |
Male and Female
1)A positive rapid antigen test for influenza is required
2)Fever >=38 degree (axillary) in the pre-dose examination
3)Body weight more than 10kg
1)Patients or their parents do not accept the assigned drug
2)A symptom duration of more than 48 hours
3)Patients who have any chronic respiratory disease, cardiovascular disease, central nervous disorder, immune dysfunction, or other chronic comorbid condition except asthma
4)Patients with severe influenza virus infection requiring inpatient treatment
600
1st name | Hisato |
Middle name | |
Last name | Ito |
Kyoto Chubu Medical Center
Department of Pediatrics
629-0197
25 Yagiueno Yagimachi Nantanshi Kyoto Japan
+81-771-42-2510
hisato527@leto.eonet.ne.jp
1st name | Masaya |
Middle name | |
Last name | Suematsu |
Kyoto Chubu Medical Center
Department of Pediatrics
629-0197
25 Yagiueno Yagimachi Nantanshi Kyoto Japan
+81-771-42-2510
masa16@koto.kpu-m.ac.jp
Kyoto Chubu Medical Center
Department of Pediatrics
Kyoto Chubu Medical Center
Department of Pediatrics
Self funding
Saiseikai Kyoto Hospital
Matsui Pediatrics Clinic
Sato Clinic
Kyoto Chubu Medical Center
25 Yagiueno Yagimachi Nantanshi Kyoto Japan
+81-771-42-2510
masa16@koto.kpu-m.ac.jp
NO
2018 | Year | 11 | Month | 27 | Day |
Unpublished
368
The efficacy of baloxavir marboxil was similar to that of NAIs, and there was no difference in side effects.
2020 | Year | 05 | Month | 10 | Day |
No longer recruiting
2018 | Year | 11 | Month | 27 | Day |
2018 | Year | 11 | Month | 01 | Day |
2018 | Year | 12 | Month | 01 | Day |
2019 | Year | 05 | Month | 31 | Day |
2020 | Year | 12 | Month | 31 | Day |
2020 | Year | 12 | Month | 31 | Day |
2020 | Year | 12 | Month | 31 | Day |
2018 | Year | 11 | Month | 27 | Day |
2020 | Year | 05 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039927
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