UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030118 |
|---|---|
| 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 |
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Basic information
Public 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-
Acronym
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease
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-
Scientific Title:Acronym
Effect of peramivir on respiratory symptom improvement in patients with respiratory disease
Region
| Japan |
Condition
Condition
Influenza A and B virus infected patient with chronic respiratory disease(asthma, COPD, pulmonary fibrosis)
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Area under the curve of influenza respiratory symptom score until 2 weeks
Key secondary outcomes
Respiratory symptom score at every 24hrs, Duration of influenza illness, Duration of fever, Respiratory functional capability, Exacerbation incidence, Virus titer, AE and ADR incidences
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
peramivir 600mg 2days dosing
Interventions/Control_2
peramivir 300mg single-dosing
Interventions/Control_3
oseltamivir 75mg bid 5days
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motokazu Kato |
Organization
Kishiwada City Hospital
Division name
Chest Disease Clinical and Research Institute
Zip code
Address
1001 Gakuhara-cho, Kishiwada, Osaka,596-8501, Japan
TEL
+81-72-445-1001
kch-43@kishiwada-hospital.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Saisho |
Organization
Shionogi&Co.,LTD
Division name
Medical Affairs
Zip code
Address
12F, Hankyu Terminal Bldg., 1-4 Shibata, 1-Chome, Kita-ku, Osaka 530-0012, Japan
TEL
+81-6-6485-5201
Homepage URL
yutaka.saisho@shionogi.co.jp
Sponsor or person
Institute
Shionogi&Co.,LTD
Institute
Department
Personal name
Funding Source
Organization
Shionogi&Co.,LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 11 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034097
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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