UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004291 |
|---|---|
| Receipt number | 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 15:37:51 |
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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
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
masaru_miura@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Pediatric acute disease clinical research network
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005146
