UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Symptom relief of gastric acid suppressants in patients with reflux esophagitis - Randomized controlled comparative study of vonoprazan and esomeprazole -
Title of the study (Brief title)	Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Region	Japan

Condition
Condition	Reflex esophagitis patients
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate GERD related symptom relief of vonoprazan and esomeprazole
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Sufficient relief of GERD symptom Change of total score of heartburn and regurgitation evaluated by GOS Questionnaire after 4,8-week treatment
Key secondary outcomes	1:The Change of individual score and the improvement of symptom (heartburn, regurgitation) evaluated using GOS /FSSG after 4,8-week treatment 2:The improvement of symptom (epigastric pain, nausea, vomiting) evaluated using GOS /FSSG after 4,8-week treatment 3:Treatment response evaluated by GOS /FSSG after 4,8-week 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	Vonoprazan 20mg p.o. once daily, 4weeks,and Vonoprazan 10mg p.o. once daily, 4weeks
Interventions/Control_2	Esomeprazole 20mg p.o. once daily, 4,8-weeks
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 or in the past. 3:Patients who answered score of 4 (moderate problem) or severer in questions about heartburn, Q2 and/or regurgitation, Q3.
Key exclusion criteria	1:Patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss. 2:Patients with confirmed or suspected malignant diseases. 3:Patients with a history of gastrointestinal resection of vagotomy. 4:Patients with a history of irritable bowel syndrome. 5:Patients whose participation in this study would be contraindicated due to complications such as serious hepatic, renal or heart disease. 6:Pregnant patients, possibly pregnant or lactating women. 7:Patients judged as inadequate in participation of this study by their attending physicians.
Target sample size	40

Research contact person
Name of lead principal investigator	Masahiro Hirano
Organization	Hirano Gastroenterology Clinic
Division name	Gastroenterology
Address	2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL	0982-26-7070
Email	gihirano@gaea.ocn.ne.jp

Public contact
Name of contact person	Masahiro Hirano
Organization	Hirano Gastroenterology Clinic
Division name	Gastroenterology
Address	2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL	0982-26-7070
Homepage URL
Email	gihirano@gaea.ocn.ne.jp

Sponsor
Institute	Hirano Gastroenterology Clinic
Institute
Department

Funding Source
Organization	Hirano Gastroenterology Clinic
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	平野消化器科

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 01 Day
Anticipated trial start date	2017 Year 01 Month 05 Day
Last follow-up date	2017 Year 04 Month 06 Day
Date of closure to data entry	2017 Year 04 Month 06 Day
Date trial data considered complete	2017 Year 04 Month 06 Day
Date analysis concluded	2017 Year 04 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2017 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030152