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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019613
Receipt No. R000022651
Scientific Title febrile Seizure Treatment Assessment of Diazepam Therapy
Date of disclosure of the study information 2015/11/04
Last modified on 2017/04/05

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Basic information
Public title febrile Seizure Treatment Assessment of Diazepam Therapy
Acronym fSTATDT study
Scientific Title febrile Seizure Treatment Assessment of Diazepam Therapy
Scientific Title:Acronym fSTATDT study
Region
Japan

Condition
Condition Febrile seuzure simplex
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Previously, When the patients of febrile seizure simplex came to the hospital, diazepam dosage was routinly applied. Since Apiril/2015, the guideline was revised ant the treatment was no longer mandatory.
We plan to evaluate whether the therapy is effective.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The effectiveness of diazepam treatment evaluated by inquiry post card. The examiner gives the card. The patient observes consious level, seizure and body temperature for 7 days. They will return the card after 8 days to reserach organization.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Diazepam treatment apply: The examiner confirms that there are no neurological findings then apply 0.3mg/kg of Diazepam. The same dose of Diazepam will be applied after 8 hours.
Interventions/Control_2 Diazepam treatment is not applied
Interventions/Control_3
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
0 years-old <=
Age-upper limit
15 years-old >=
Gender Male and Female
Key inclusion criteria The patients of febrile seizure simplex without previous seizure history
Key exclusion criteria Informed consent was not meet
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noboru Yoshida
Organization Juntendo University Nerima Hospital
Division name Pediatrics Division
Zip code
Address 3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL 03-5923-3111
Email noyoshi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noboru Yoshida
Organization Juntendo University Nerima Hospital
Division name Pediatrics Division
Zip code
Address 3-1-10 Takanodai Nerima-ku Tokyo, Japan
TEL 03-5923-3111
Homepage URL
Email noyoshi@juntendo.ac.jp

Sponsor
Institute Juntendo University Nerima Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 11 Month 04 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
2015 Year 10 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 01 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 11 Month 02 Day
Last modified on
2017 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022651

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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