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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030118
Receipt No. 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

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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
Email 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
Email yutaka.saisho@shionogi.co.jp

Sponsor
Institute Shionogi&Co.,LTD
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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