UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034443
Receipt number R000039277
Scientific Title Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.
Date of disclosure of the study information 2018/10/11
Last modified on 2019/10/16 17:34:37

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Basic information

Public title

Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.

Acronym

Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.

Scientific Title

Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.

Scientific Title:Acronym

Comparison of gastric transit time after ingestion of alcoholic drink and glucose solution by ultrasound assessment of gastric volume.

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the difference of gastric transit time after ingestion of alcoholic drink and glucose solution.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The cross-sectional surface area of
the gastric antrum measured by ultrasound.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 30ml of whisky and 120ml of water.

Interventions/Control_2

The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 150ml of 11.2% glucose solution.

Interventions/Control_3

The change of the cross-sectional surface area of the gastric antrum with time after after ingestion of 150ml of water.

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

Key inclusion criteria

Persons who fills everything the following
1) a person of 20years or more
2) a person who gives written informed
consent

Key exclusion criteria

1. a person who have gastrointestinal lesion.
2. a person who are alcoholic intolerance.
3. a person who are ineligible in the opinion of the investigator.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tadashi
Middle name
Last name Okabe

Organization

Hitachi, Ltd. Hitachinaka General Hospital

Division name

Department of Anesthesiology

Zip code

312-0057

Address

20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN

TEL

029-354-5111

Email

t-okabe@nms.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Okabe

Organization

Hitachi, Ltd. Hitachinaka General Hospital

Division name

Department of Anesthesiology

Zip code

312-0057

Address

20-1 Ishikawa-cho Hitachinaka-shi Ibaraki 312-0057 JAPAN

TEL

029-354-5111

Homepage URL


Email

t-okabe@nms.ac.jp


Sponsor or person

Institute

Hitachi, Ltd. Hitachinaka General Hospital

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

the Hitachi Ltd., Hitachi General Hospital Research Ethics Committee

Address

2-1-1 jyonan-cho Hitachi-shi Ibaraki

Tel

029-423-8333

Email

masahiro.miura.cz@hitachi.com


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

2018 Year 10 Month 11 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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

Main results already published

Date of protocol fixation

2018 Year 10 Month 09 Day

Date of IRB

2018 Year 10 Month 01 Day

Anticipated trial start date

2018 Year 10 Month 11 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 10 Month 11 Day

Last modified on

2019 Year 10 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039277


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name