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

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 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


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

Value
https://center6.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