UMIN-CTR Clinical Trial

Basic information
Public title	Symptomatic effect and serum gastrin level after treatment with proton pump inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Acronym	Symptomatic effect and serum gastrin level after treatment with proton pump inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Scientific Title	Symptomatic effect and serum gastrin level after treatment with proton pump inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Scientific Title:Acronym	Symptomatic effect and serum gastrin level after treatment with proton pump inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Region	Japan

Condition
Condition	GERD
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study was to investigate the effects of Esomeprazole 20 mg once a day for patients with Pcab resistant reflux esophagitis with remnant symptoms even after oral administration of Vonoprazan 20 mg for 4 weeks or more after four weeks of effect on gastrointestinal symptoms Are compared and examined using various scores of FSSG which is a patient self-entry questionnaire as an index. We will also examine changes in symptoms other than GERD symptoms including safety before and after switching.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	the change in FSSG total score before and 4 weeks after treatment with Esomeprazole
Key secondary outcomes	1. Score change of each of the reflux score and exercise failure score after 2 or 4 weeks evaluated by the FSSG questionnaire 2. Total core change after 2 weeks evaluated by FSSG questionnaire 3. Therapeutic reactivity after 2 or 4 weeks evaluated in the GOS questionnaire 4. Serum gastrin level change before and after esomeprazole administration 5. tolerability during administration of both drugs

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Esomeprazole 20 mg capsule Orally administered once a day for 4 weeks
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.Patient who gave written consent to study participation by free documentation and verbally enough explanation. 2.Patients aged 20 years and older at 2 years of age 3.Three patients diagnosed as reflux esophagitis. 4. Patients with Pcab resistant reflux esophagitis whose gastrointestinal symptoms remained despite intake of Vonoprazan for 4 weeks or more at the time of registration. 5.Patients with total score of 8 or more in the 5FSSG interview sheet.
Key exclusion criteria	(1) Patients with warning findings such as vomiting subject to endoscopic examination, gastrointestinal bleeding (including findings of hematemesis, venous drainage, anemia, etc.), and rapid weight loss. (2) Patients with malignant lesions confirmed or suspected of malignant lesions. (3) A patient with a history of gastrointestinal resection and vagotomy. (4) Patients with irritable bowel syndrome. (5) Patients who are difficult to participate in this study due to mergers of severe liver disease, kidney disease, heart disease etc. (6) Pregnant women, lactating women or lactating women who may be pregnant. (7) Patients who other doctors judged inappropriate as subjects of this study.
Target sample size	25

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shinichi Ishihara
Organization	Ishihara Gastroenterology Clinic
Division name	Gastroenterology
Zip code
Address	Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture
TEL	0877-63-6677
Email	ccy63890@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Shinichi Ishihara
Organization	Ishihara Gastroenterology Clinic
Division name	Gastroenterology
Zip code
Address	Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture
TEL	0877-63-6677
Homepage URL
Email	ccy63890@yahoo.co.jp

Sponsor
Institute	Ishihara Gastroenterology Clinic
Institute
Department

Funding Source
Organization	Ishihara Gastroenterology Clinic
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	2018 Year 01 Month 23 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	2017 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2018 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035335

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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