Unique ID issued by UMIN | UMIN000030118 |
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Receipt number | R000034097 |
Scientific Title | Effect of peramivir on respiratory symptom improvement in patients with respiratory disease -comparatve evaluation: peramivir maximal dose (600mg) repeat-dosing (2days) vs standard dose (300mg) single-dosing vs oseltamivir (75mg bid) 5days treatment- |
Date of disclosure of the study information | 2017/11/26 |
Last modified on | 2019/01/30 12:44:24 |
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease -comparatve evaluation: peramivir maximal dose (600mg) repeat-dosing (2days) vs standard dose (300mg) single-dosing vs oseltamivir (75mg bid) 5days treatment-
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease -comparatve evaluation: peramivir maximal dose (600mg) repeat-dosing (2days) vs standard dose (300mg) single-dosing vs oseltamivir (75mg bid) 5days treatment-
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease
Japan |
Influenza A and B virus infected patient with chronic respiratory disease(asthma, COPD, pulmonary fibrosis)
Pneumology | Adult |
Others
NO
To assess area under the curve of influenza respiratory symptom score until 2 weeks in influenza A and B virus infected patient with chronic respiratory disease(asthma, COPD, pulmonary fibrosis)
Safety,Efficacy
Confirmatory
Not applicable
Area under the curve of influenza respiratory symptom score until 2 weeks
Respiratory symptom score at every 24hrs, Duration of influenza illness, Duration of fever, Respiratory functional capability, Exacerbation incidence, Virus titer, AE and ADR incidences
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
Institution is not considered as adjustment factor.
3
Treatment
Medicine |
peramivir 600mg 2days dosing
peramivir 300mg single-dosing
oseltamivir 75mg bid 5days
16 | years-old | <= |
80 | years-old | > |
Male and Female
1)Both Inpatient and outpatient
2)Patients with influenza symptoms confirmed by all of the following,
Influenza rapid diagnosis test:positive
Fever more than or qual 37.5 degree (axillary) during the predose examinations or more than 4 hours after dosing of antipyretics if they were taken.
Patients showing at least total of 3 points of respiratory symptoms (cough, sore throat, nasal congestion) associated
At least more than 2 points (moderate) of one general symptom (either headache, feverishness or chills, muscle or joint pain, or fatigue)
3)The time interval between the onset of symptoms and the predose examinations (Screening)is 48 hours or less.
1)Patients who need antibacterial or antifungal or antiviral drugs for treatment of underlying dieases
2)patients with chronic respiratory who had been in ventilator settings
3)patients receving dialysis or with impaired renal function (Ccr<50mL/min)
4)within previously 7days, patients who were treated with either of 4NA inhibitor (oseltamivir, zanamivir, peramivir and laninamivir)and amantadine
5)pregnant, breast-feeding woman
210
1st name | |
Middle name | |
Last name | Motokazu Kato |
Kishiwada City Hospital
Chest Disease Clinical and Research Institute
1001 Gakuhara-cho, Kishiwada, Osaka,596-8501, Japan
+81-72-445-1001
kch-43@kishiwada-hospital.com
1st name | |
Middle name | |
Last name | Yutaka Saisho |
Shionogi&Co.,LTD
Medical Affairs
12F, Hankyu Terminal Bldg., 1-4 Shibata, 1-Chome, Kita-ku, Osaka 530-0012, Japan
+81-6-6485-5201
yutaka.saisho@shionogi.co.jp
Shionogi&Co.,LTD
Shionogi&Co.,LTD
Profit organization
NO
2017 | Year | 11 | Month | 26 | Day |
Unpublished
Completed
2017 | Year | 10 | Month | 06 | Day |
2017 | Year | 11 | Month | 26 | Day |
2019 | Year | 02 | Month | 16 | Day |
2017 | Year | 11 | Month | 25 | Day |
2019 | Year | 01 | Month | 30 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034097
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