UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035028
Receipt No. 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 2019/01/09

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Acronym Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Scientific Title Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Scientific Title:Acronym Effect and safety of Baloxavir Marboxil in children with influenza: multicenter randomized controlled study
Region
Japan

Condition
Condition Influenza
Classification by specialty
Infectious disease Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare Baloxavir marboxil, Oseltamivir and Laninamivir with efficacy and safety in pediatric patients with influenza.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The time to resolution of fever
Key secondary outcomes 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

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Baloxavir marboxil
Interventions/Control_2 Oseltamivir
Interventions/Control_3 Laninamivir
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

Not applicable
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisato Ito
Organization Kyoto Chubu Medical Center
Division name Department of Pediatrics
Zip code
Address 25 Yagiueno Yagimachi Nantanshi Kyoto Japan
TEL +81-771-42-2510
Email hisato527@leto.eonet.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Suematsu
Organization Kyoto Chubu Medical Center
Division name Department of Pediatrics
Zip code
Address 25 Yagiueno Yagimachi Nantanshi Kyoto Japan
TEL +81-771-42-2510
Homepage URL
Email masa16@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Chubu Medical Center
Department of Pediatrics
Institute
Department

Funding Source
Organization Kyoto Chubu Medical Center
Department of Pediatrics
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Saiseikai Kyoto Hospital
Matsui Pediatrics Clinic
Sato Clinic
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
2018 Year 11 Month 27 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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 27 Day
Last modified on
2019 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039927

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.