UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.
Title of the study (Brief title)	Study of symptom improvement effect of gastric secretion inhibitors in patients with reflux esophagitis.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the clinical symptom improvement effect of Vonoprazan compared with esomeprazole
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change of total score evaluated using FSSG
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan 20mg oral once a day, 4weeks
Interventions/Control_2	Esomeprazole 20mg oral once a day, 4weeks
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.The patients aged 20 years or older. 2.The patients who are diagnosed as having reflux esophagitis by physician. 3.The patients who have GERD symptom (heartburn or acid regurgitation) at least once a week.
Key exclusion criteria	1.The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss. 2.The patients with confirmed or suspected malignant diseases. 3.The patients with a history of gastrointestinal resection of vagotomy. 4.The patients with a history of irritable bowel syndrome. 5.The patients whose participation in this study would be contraindicated due to complications such as serious heaptic, renal or heart disease. 6.The Pregnant patients or possibly pregnant patients. 7.The patients prohibited the participant of this study by their attending physicians. 8.The patients who took esomeprazole or vonoprazan within 4 weeks.
Target sample size	40

Research contact person
Name of lead principal investigator	Tsutomu Masuda
Organization	Ikoma Gastorenteroproctorogy Clinic
Division name	Gastroenterology
Address	7-10 Honmachi, Ikoma-shi, Nara
TEL	0743-71-8050
Email	t-masuda@gaia.eonet.ne.jp

Public contact
Name of contact person	Tsutomu Masuda
Organization	Ikoma Gastorenteroproctorogy Clinic
Division name	Gastroenterology
Address	7-10 Honmachi, Ikoma-shi, Nara
TEL	0743-71-8050
Homepage URL
Email	t-masuda@gaia.eonet.ne.jp

Sponsor
Institute	Ikoma Gastorenteroproctorogy Clinic
Institute
Department

Funding Source
Organization	Ikoma Gastorenteroproctorogy 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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 05 Month 15 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 09 Month 01 Day
Last modified on	2017 Year 09 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033145