UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012898
Receipt number R000015069
Scientific Title Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas
Date of disclosure of the study information 2014/01/19
Last modified on 2014/08/19 22:09:15

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Basic information

Public title

Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas

Acronym

Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas

Scientific Title

Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas

Scientific Title:Acronym

Establishment of the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to establish the method for evaluating the remaining alcohol after intravenous injection of alcohol-containing drugs by analysis of expired gas and the method for decreasing the remaining alcohol.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Breath and blood alcohol concentration

Key secondary outcomes

Subjective symptom


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

Medicine

Interventions/Control_1

The single intravenous injection of 14.6mL/m2 of ethanol

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

Healthy adult
Those who do not have a problem in alcohol-metabolizing enzyme activity at an alcoholic patch test

Key exclusion criteria

Those who experience a remarkable face flush or poor health after about 100 ml of beer drinking
Those to whom the skin becomes red by ethanol disinfection

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nao Odagiri

Organization

Hirosaki University School of Medicine and Hospital

Division name

Pharmaceutical department

Zip code


Address

53 Hon-cho, Hirosaki, Aomori

TEL

0172-33-5111

Email

odagiri-hki@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nao Odagiri

Organization

Hirosaki University School of Medicine and Hospital

Division name

Pharmaceutical department

Zip code


Address

53 Hon-cho, Hirosaki, Aomori

TEL

0172-33-5111

Homepage URL


Email

odagiri-hki@umin.ac.jp


Sponsor or person

Institute

Pharmaceutical department, Hirosaki University School of Medicine and Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

弘前大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 01 Month 19 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

Completed

Date of protocol fixation

2014 Year 01 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 20 Day

Last follow-up date

2014 Year 07 Month 31 Day

Date of closure to data entry

2014 Year 10 Month 31 Day

Date trial data considered complete

2014 Year 10 Month 31 Day

Date analysis concluded

2014 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 01 Month 19 Day

Last modified on

2014 Year 08 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015069


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name