UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025825 |
|---|---|
| Receipt number | R000029700 |
| Scientific Title | Pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2020/06/16 09:24:01 |
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Basic information
Public title
Pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol
Acronym
Pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol
Scientific Title
Pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol
Scientific Title:Acronym
Pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol
Region
| Japan |
Condition
Condition
A person (an adult) who may drink
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate pharmacokinetics of breath alcohol and acetaldehyde after mouth rinse using alcohol
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in breath alcohol and acetaldehyde concentrations for about 20 minutes after mouth rinse using alcohol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention is a 1 day, 2 hours. A subject is sampled his exhaled gas 13 times for 20 minutes after mouth rinse using alcohol beverage of 5 % ethanol. After that, he use a mouth wash solution 'Listerine' and stay for 30 minutes, and then he is again sampled his exhaled gas in the same way as the last time.
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
1) 20 <= years-old
2) Male and Female
3) A person who has ever drunken
4) A person who is provided sufficient explanations about this study and consented to it in writing by his own free will
Key exclusion criteria
1) a person who has ever had any allergy symptoms by drinking alcohol beverage or using mouth wash solution
2) a person who has any airway diseases or liver diseases
3) a person who is probably pregnant or is during pregnancy
4) a person who is during the lactation
5) 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, Department of Legal Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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 Hospital
Address
Minami-kogushi 1-1-1, Ube, Yamaguchi 755-8505 JAPAN
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 24 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000029700
Publication of results
Published
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000029700
Number of participants that the trial has enrolled
46
Results
Breath acetaldehyde (Ach) levels showed an immediate increase, followed by an almost exponential decrease in both groups, but concentrations in the F group remained higher than those in the NF group throughout the measurement period.
This was reflected in Cmax and AUC.
These tendencies were also shown in time-course changes after mouth washing with Listerine.
AUC values of Ach in both groups and Cmax of Ach in NF group decreased by using Listerine.
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 | 01 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 30 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029700
| 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 |
