UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006225 |
|---|---|
| Receipt number | R000007348 |
| Scientific Title | Effect of antiepileptic drugs on pharmacokinetics of midazolam during anesthesia in patients with intellectual disability |
| Date of disclosure of the study information | 2011/08/24 |
| Last modified on | 2012/03/23 16:33:42 |
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Basic information
Public title
Effect of antiepileptic drugs on pharmacokinetics of midazolam during anesthesia in patients with intellectual disability
Acronym
Effect of antiepileptic drugs on pharmacokinetics of midazolam
Scientific Title
Effect of antiepileptic drugs on pharmacokinetics of midazolam during anesthesia in patients with intellectual disability
Scientific Title:Acronym
Effect of antiepileptic drugs on pharmacokinetics of midazolam
Region
| Japan |
Condition
Condition
dental patients with epilepsy
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of antiepileptic drugs on pharmacokinetics of midazolam
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We measured the serum concentration of midazolam after injection, and compared them between the groups. More over, we compared clinical effects.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants of the present study were dental patients with intellectual disability in Okayama University Hospital.
Key exclusion criteria
Patients taking other antiepileptic drugs without carbamazepine or phenytoin.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Miyawaki |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1, Shikata-chou, Kita-ku, Okayama 700-8525, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Dental Anesthesiology and Special Care Dentistry
Zip code
Address
2-5-1, Shikata-chou, Kita-ku, Okayama 700-8525, Japan
TEL
086-223-7151
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | Month | 24 | 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
| 2009 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
We compare the patients receiving carbamazepine and/or phenytoin with those receiving no antiepileptic drugs.
Management information
Registered date
| 2011 | Year | 08 | Month | 24 | Day |
Last modified on
| 2012 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007348
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
