UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012255
Receipt number R000014332
Scientific Title Effectiveness of phenytoin-caffeine combination in general seizure
Date of disclosure of the study information 2013/12/20
Last modified on 2013/11/09 12:36:40

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Basic information

Public title

Effectiveness of phenytoin-caffeine combination in general seizure

Acronym

The study of phenytoin-caffeine combination in general seizure

Scientific Title

Effectiveness of phenytoin-caffeine combination in general seizure

Scientific Title:Acronym

The study of phenytoin-caffeine combination in general seizure

Region

Asia(except Japan)


Condition

Condition

Epilepsy with general seizure

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effectiveness of phenytoin-caffeine combination in general seizure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Phase II


Assessment

Primary outcomes

Seizure frequency, seizure reduction>50%, 6 month remission

Key secondary outcomes

Plasma phenytoin concentration, and adverse drug reaction.


Base

Study type


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patients receive phenytoin 5mg/kg

Interventions/Control_2

Patients receive phenytoin 5mg/kg-caffeine 2.5mg/kg

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

1 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

General seizure

Key exclusion criteria

Diabetes Mellitus, acute or chronic myocard infarction, hypertension, chronic liver diseases

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Dr. Widyati, MClin Pharm

Organization

dr. Ramelan Navy Hospital

Division name

Pharmacy department

Zip code


Address

Jl. Ketintang Baru Selatan IV no 71 Surabaya-Jawa Timur, Indonesia

TEL

6231081331383111

Email

widyatiw@yahoo.com


Public contact

Name of contact person

1st name
Middle name
Last name Dr. Widyati, MClin Pharm

Organization

dr. Ramelan Navy Hospital

Division name

Pharmacy department

Zip code


Address

Surabaya-Jawa Timur, Indonesia

TEL

6231081331383111

Homepage URL


Email

widyatiw@yahoo.com


Sponsor or person

Institute

Directorate General of Higher Education, Ministry of Education and Culture

Institute

Department

Personal name



Funding Source

Organization

Directorate General of Higher Education, Ministry of Education and Culture Scholarship

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Indonesia


Other related organizations

Co-sponsor

University of Gajah Mada, University of Surabaya

Name of secondary funder(s)

University of Surabaya, dr. Ramelan Navy Hospital


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

dr. Ramelan Navy Hospital


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 20 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

2012 Year 12 Month 20 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 25 Day

Last follow-up date

2013 Year 06 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 20 Day

Date trial data considered complete

2013 Year 12 Month 20 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 11 Month 09 Day

Last modified on

2013 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014332


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name