UMIN-CTR Clinical Trial

Basic information
Public title	Drink test to assess gastric function
Acronym	Drink test to assess gastric function
Scientific Title	Drink test to assess gastric function
Scientific Title:Acronym	Drink test to assess gastric function
Region	Japan

Condition
Condition	Functional Dyspepsia
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate relationship between uper-gastrointestinal symptoms and gastric function
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time point and amount of liquid meal when patient stopped continuous drinking due to upper-abdominal symptoms
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Continuous liquid meal drinking(15ml/min) untilstoppage of drinking due to upper-abdominal symptoms
Interventions/Control_2	Continuous liquid meal drinking(15ml/min) untilstoppage of drinking due to upper-abdominal symptoms
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients of functional dyspepsia and healthy volunteer
Key exclusion criteria	nothing
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tatsuhiro Masaoka
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address	35 Shinano-machi, Shinjuku Tokyo
TEL	03-5363-3790
Email	masaoka@z6.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Tatsuhiro Masaoka
Organization	Keio University School of Medicine
Division name	Division of Gastroenterology and Hepatology,Department of Internal Medicine
Zip code
Address	35 Shinano-machi, Shinjuku Tokyo
TEL	0353633790
Homepage URL
Email	masaoka@z6.keio.jp

Sponsor
Institute	Division of Gastroenterology and Hepatology,Department of Internal Medicine,Keio University School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology and Hepatology,Department of Internal Medicine,Keio University School of Medicine
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
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

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 28 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
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	2015 Year 03 Month 27 Day
Date of IRB	2015 Year 03 Month 23 Day
Anticipated trial start date	2015 Year 03 Month 27 Day
Last follow-up date	2021 Year 04 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	2015 Year 05 Month 28 Day
Last modified on	2021 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020533