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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010024
Receipt No. 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

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Basic information
Public 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.
Acronym 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.
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.
Scientific Title:Acronym 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.
Region
Japan

Condition
Condition Childhood influenza infections
Classification by specialty
Medicine in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical and virology effects of NA inhibitor on influenza virus (Sub-types; A/H1N1pdm09, A/H3N2) in Childhood.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes -Time to return to normal body temperature (under 37.5 degrees)
-Influenza virus titer (TCID50)
Key secondary outcomes -Duration of influenza symptoms patients
-IC50 in NA inhibition assays of NA inhibitors
-Virus mutation after treatment of NA inhibitors

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oseltamivir
Interventions/Control_2 Zanamivir
Interventions/Control_3 Peramivir
Interventions/Control_4 Laninamivir
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
4 years-old <=
Age-upper limit
11 years-old >
Gender Male and Female
Key inclusion criteria 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).
Key exclusion criteria History of hypersensitivity caused by neuraminidase inhibitors. Patients who are deemed to be inappropriate by the investigator.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuo Hirotsu
Organization Hirotsu Clinic
Division name Internal Medicine, Pediatrics
Zip code
Address Hisamoto 3-6-1-212, Takatsu-ku, Kawasaki, 231-0011, Japan
TEL 044-822-1933
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hirotsu Clinic
Division name Internal Medicine, Pediatrics
Zip code
Address
TEL 044-822-1933
Homepage URL
Email

Sponsor
Institute Hirotsu Clinic
Institute
Department

Funding Source
Organization SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor SHIONOGI & CO., LTD.
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 廣津医院(神奈川県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

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
2013 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
2013 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 13 Day
Last modified on
2013 Year 12 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011738

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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