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
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
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
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
