UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029008 |
|---|---|
| Receipt number | R000033190 |
| Scientific Title | The research related to pharmacokinetics of alcohol and acetaldehyde in oral cavity |
| Date of disclosure of the study information | 2017/09/11 |
| Last modified on | 2020/06/15 17:42:44 |
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Basic information
Public title
The research related to pharmacokinetics of alcohol and acetaldehyde in oral cavity
Acronym
The research related to pharmacokinetics of alcohol and acetaldehyde in oral cavity
Scientific Title
The research related to pharmacokinetics of alcohol and acetaldehyde in oral cavity
Scientific Title:Acronym
The research related to pharmacokinetics of alcohol and acetaldehyde in oral cavity
Region
| Japan |
Condition
Condition
A healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate pharmacokinetics of alcohol and acetaldehyde in oral cavity
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
<Study1> change in alcohol and acetaldehyde concentrations in alcohol beverage kept in oral cavity
<Study 2 and 3> change in salivary alcohol and acetaldehyde concentrations after mouth rinse using alcohol beverage
Key secondary outcomes
Alcohol sensitivity by alcohol patch test and ADH1B/ALDH2 genotype based on PCR method using oral mucosa.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention is a 1 day, about 3.5 hours during Study 1-3.
<Study 1> A subject keeps and rinses 20ml of 5% alcohol beverage in his/her oral cavity for 30 seconds, 2, 5 and 10 minutes at intervals of 30 minutes. And then, he/she is sampled each solution.
<Study 2> A subject is sampled his/her saliva 14 times for 20 minutes after keeping and rinsing 20ml of 5% alcohol beverage for 30 seconds in his/her oral cavity.
<Study 3> A subject brushes his/her teeth and tongue and washes carefully his/her mouth using water after 30 minutes from Study 1. And then, he/she is again sampled his/her saliva in the same way as Study 2.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･20<= years-old
･Male and Female
･A person who has ever drunken
･A person who is provided sufficient explanations about this study and consented to it in writing by his own free will
Key exclusion criteria
･a person who has ever had any allergy symptoms by drinking alcohol beverage
･a person who has any airway diseases or liver diseases
･a person who is probably pregnant or is during pregnancy
･a person who is during the lactation
･an inappropriate person for this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Fujimiya |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
fujimiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Himemiya-Hakucho |
Organization
Graduate School of Medicine, Yamaguchi University
Division name
Department of Legal Medicine
Zip code
7558505
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
TEL
0836-22-2234
Homepage URL
haku.a@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center For Clinical Research, Yamaguchi University Hospita
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
山口大学医学部（山口県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 11 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000033190
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000033190
Number of participants that the trial has enrolled
44
Results
<Study1>
With the increase in the holding time, ethanol levels decreased but acetaldehyde levels increased; the ethanol/acetaldehyde ratio of the Flusher group was higher than that of the Non-Flusher group on holding for 10 min.
<Study 2 and 3>
Time-course changes in median values of salivary ethanol and acetaldehyde levels in Flusher and Non-Flusher groups were similar. After brushing teeth and mouthwashing by water, the values showed a similar tendensy.
Results date posted
| 2020 | Year | 06 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Reffer to Eligibility
Participant flow
Reffer to Study design
Adverse events
None
Outcome measures
Reffer to Assessment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033190
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
