UMIN-CTR Clinical Trial

Basic information
Public title	The factors related with GI symptoms in patients with GERD
Acronym	GI symptoms in GERD patients
Scientific Title	The factors related with GI symptoms in patients with GERD
Scientific Title:Acronym	GI symptoms in GERD patients
Region	Japan

Condition
Condition	reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate association between symptoms of patients with reflux esophagitis (RE) and their factors in a cross-sectional manner.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the association between total score evaluated by F-scale and fasting blood gastrin level
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) People aged 20 or older who have provided written consent to participate in this study 2) RE patients under treatment with acid suppressants
Key exclusion criteria	1) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss 2) Patients with a confirmed or suspected malignant lesion 3) Patients with a history of gastrointestinal resection or vagotomy 4) Patients with irritable bowel syndrome 5) Hypergastrinemic patients with renal failure, ZE syndrome, etc 6) Patients complicated by serious hepatic, renal, cardiac, or other diseases 7) Patients on NSAIDs and low-dose aspirin 8) Patients with pernicious anemia 9) Other patients judged by their attending physicians to be inappropriate for this study
Target sample size	600

Research contact person
Name of lead principal investigator	1st name Akiko Middle name Last name Shiotani
Organization	Kawasaki Medical School
Division name	Internal Medicine Division of Gastroenterology
Zip code	701-0192
Address	577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL	0864621111
Email	shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name Akiko Middle name Last name Shiotani
Organization	Kawasaki Medical School
Division name	Internal Medicine Division of Gastroenterology
Zip code	701-0192
Address	577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL	0864621111
Homepage URL
Email	shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	AstraZeneca
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kawasaki Medical School
Address	577 Matushima Kurasiki city Okayama 701-0192 Japan
Tel	0864621111
Email	kmsrec@med.kawasaki-m.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	2018 Year 06 Month 01 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	311
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	2018 Year 05 Month 14 Day
Date of IRB	2020 Year 05 Month 24 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 12 Month 31 Day

Other
Other related information	non

Management information
Registered date	2018 Year 05 Month 14 Day
Last modified on	2021 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036675

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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