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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004291
Receipt No. R000005146
Scientific Title A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode .
Date of disclosure of the study information 2010/09/29
Last modified on 2013/09/29

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Basic information
Public title A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode .
Acronym FS-1
Scientific Title A randomized, multicenter, controlled trial of prophyractic use of diazepam for recurrence of febrile seizures during single febrile episode .
Scientific Title:Acronym FS-1
Region
Japan

Condition
Condition Simple febrile seizure
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Optimization of the diazepam prophylac efficacy and safety among three different usages of diazepam; 1 dosage, 2 dosage, intermittent administration during febrile period, in children just after simple febrile seizures.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes proportion of patients occurring febrile seizures after registration.
Key secondary outcomes adverse events frequency and duration
prevalence of CNS infection, neurological disease and metabolic disease

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Single dose of diazepam 0.5mg/kg
Interventions/Control_2 Two sequential doses of diazepam 0.5mg/kg with eight hours interval
Interventions/Control_3 diazepam 0.3mg/kg/dose 3 times a day during febrile period (terminated after confirmation that fever free status maintains at least 24 hours)
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
6 months-old <=
Age-upper limit
72 months-old >
Gender Male and Female
Key inclusion criteria 1. single 15 minutes or less generalized seizure episode within 72 hours
2. no prior use of anticonvulsant within 72 hours
3.body temperature >= 38.0 degree Celsius at visiting
4. six months to five years old.
5. alert conscious status with spontaneous eye opening and crying or spontaneous speech, and moves spontaneously or purposefully without the paralysis
6. no more than single history of afebrile seizures
7. absence of neurological disorder(include mental retardation and developmental disorder), malformation syndrome, dysmetabolic syndrome and electrolyte abnormality.
8. written consent from the parents
Key exclusion criteria None
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Miura
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Clinical Research support center
Zip code
Address 2-8-29 Musashinodai, Fuchu-shi, TOKYO
TEL 042-300-5111
Email yoshihiko_morikawa@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiko Morikawa
Organization Tokyo Metropolitan Children's Medical Center
Division name Department of Clinical Research
Zip code
Address 2-8-29 Musashinodai, Fuchu-shi, TOKYO
TEL 042-300-5111
Homepage URL
Email masaru_miura@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Pediatric acute disease clinical research network
Institute
Department

Funding Source
Organization Tokyo Metropolitan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 都立大塚病院(東京都)
都立小児総合医療センター(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 29 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
2010 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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
2010 Year 09 Month 29 Day
Last modified on
2013 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005146

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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