UMIN-CTR Clinical Trial

Basic information
Public title	Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients -Randomized controlled comparative test of vonoprazan and esomeprazole-
Acronym	Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Scientific Title	Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients -Randomized controlled comparative test of vonoprazan and esomeprazole-
Scientific Title:Acronym	Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Region	Japan

Condition
Condition	Reflux esophagitis patients
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The symptom improvement effect and endoscopic improvement of gastric acid secretion inhibitors for reflux esophagitis patients
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Consideration of the symptom improvement value using the interview sheet after4,8 week treatment and the endoscopic improvement effect of after 8 week treatment
Key secondary outcomes	The safety value of the treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonopurazan 20mg P.o.once daily,8weeks
Interventions/Control_2	Esomeprazole 20mg P.o.once daily,8weeks
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.Patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation. 2.Patients who were confirmed reflux esophagitis with grade A-D of LA classification at the entry.
Key exclusion criteria	1.Patients with a history of gastrointestinal resection or vagotomy. 2.Patients with confirmed or susupected malignant disease. 3.Pregnancy or lactation. 4.Past history of allergy for the drugs used in this therapy. 5.Ptients with sever liver dysfunction,sever renal dysfunction,sever hert dysfunction. 6.Ptients who are disqualifid for the study by physicians.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Syuji Inoue
Organization	National Hospital Organization National Kochi Hospital
Division name	gastroenterology
Zip code
Address	1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL	088-844-3111
Email	inouesh@kochi2.hosp.go.jp

Public contact
Name of contact person	1st name Middle name Last name Syuji Inoue/Sizuka Eguthi
Organization	National Hospital Organization National Kochi Hospital
Division name	gastroenterology
Zip code
Address	1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL	088-844-3111
Homepage URL
Email	inouesh@kochi2.hosp.go.jp

Sponsor
Institute	National Hospital Organization National Kochi Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization National Kochi Hospital
Organization
Division
Category of Funding Organization	Other
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	独立行政法人国立病院機構高知病院

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 04 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 08 Month 03 Day
Date of IRB	2019 Year 04 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 04 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 06 Month 09 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 02 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032552