UMIN-CTR Clinical Trial

Basic information
Public title	A single center cross-sectional study on evaluation of gastric hypersensitivity by gastric function test
Acronym	A single center cross-sectional study on evaluation of gastric hypersensitivity
Scientific Title	A single center cross-sectional study on evaluation of gastric hypersensitivity by measuring gastric pressure and CO2 injection volume under endoscopy
Scientific Title:Acronym	Parallel-group comparative study on evaluation of gastric hypersensitivity
Region	Japan

Condition
Condition	Drug-registant functional dyspepsia(FD)
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the validity of gastric hypersensitivity evaluation by measuring gastric pressure and CO2 injection volume under endoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Difference of gastric pressure and CO2 injection volume between drug-resistant FD patients and non-FD patients when their symptoms appear 2. Gastric pressure, cut-off value of CO2 injection volume, sensitivity and specificity of drug-resistant FD patients
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Age: Over 20 years old and younger than 80 years old 2. Gender: Both males and females 3. Outpatient 4. Patients who have been diagnosed with FD and their symptoms have not improved by drug therapy (PPI, prokinetics) 5. Patients who understood study, and provided written consent based on their own will
Key exclusion criteria	1. Patients with malignancy 2. Patients with suspected with active infection 3. Pregnant or possibility of being pregnant, and those who are breath feeding 4. Study participation decided to be contraindicated by the parson in charge
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Katsuhiko Middle name Last name Iwakiri
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Email	k-iwa@nms.ac.jp

Public contact
Name of contact person	1st name Eri Middle name Last name Momma
Organization	Nippon Medical School
Division name	Department of Gastroenterology
Zip code	113-8603
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL	03-3822-2131
Homepage URL
Email	eri-momma@nms.ac.jp

Sponsor
Institute	Nippon Medical School Hospital
Institute
Department

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	Nippon Medical School Hospital
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel	03-3822-2131
Email	eri-momma@nms.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	2020 Year 02 Month 03 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	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 20 Day
Date of IRB	2018 Year 02 Month 23 Day
Anticipated trial start date	2018 Year 03 Month 20 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We investigated whether this system of measuring CO2 injection volume and gastric pressure is useful for evaluating gastric hypersensitivity in drug-resistant FD patients who are strongly suspected to have gastric hypersensitivity.

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044741