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Recruitment status Completed
Unique ID issued by UMIN UMIN000006225
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007348


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