UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029008
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email haku.a@yamaguchi-u.ac.jp

Sponsor
Institute Yamaguchi University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.