UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040770
Receipt number R000046556
Scientific Title Pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with alcohol
Date of disclosure of the study information 2020/06/15
Last modified on 2022/12/19 08:56:12

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Basic information

Public title

Pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with alcohol

Acronym

Pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with alcohol

Scientific Title

Pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with alcohol

Scientific Title:Acronym

Pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with alcohol

Region

Japan


Condition

Condition

A healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To examine a relationship between pharmacokinetics of breath alcohol and acetaldehyde after mouthwashing with several kinds of alcohol and alcohol sensitivity (ALDH2 and ADH1B genotype)

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes in breath alcohol and acetaldehyde concentrations after mouthwashing with several kinds of alcohol

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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Intervention is 3 days. On each day, a subject washes the mouth using by 180 ml alcohol beverage of different 3 concentration including 0.1 g/kg of body weight, 0.3 g/kg of BW or 0.5 g/kg of BW ethanol, respectively, within about 5 minutes. And then, he is sampled his exhaled gas over time for 1 hour, respectively.

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 unit of alcohol.
*A person who is standard weight (=>18.5 and <25) based on BMI (body mass index)
*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

60


Research contact person

Name of lead principal investigator

1st name Ayako
Middle name
Last name HIMEMIYA-HAKUCHO

Organization

Graduate School of Medicine, Yamaguchi University

Division name

Department of Legal Medicine

Zip code

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi

TEL

0836-22-2234

Email

haku.a@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

755-8505

Address

Minami-kogushi 1-1-1, Ube, Yamaguchi

TEL

0836-22-2234

Homepage URL


Email

haku.a@yamaguchi-u.ac.jp


Sponsor or person

Institute

Yamaguchi University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

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

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)
(Yamaguchi University School of Medicine, Yamaguchi)


Other administrative information

Date of disclosure of the study information

2020 Year 06 Month 15 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

No longer recruiting

Date of protocol fixation

2020 Year 05 Month 29 Day

Date of IRB

2020 Year 07 Month 22 Day

Anticipated trial start date

2020 Year 07 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 06 Month 15 Day

Last modified on

2022 Year 12 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046556


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name