UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients -a randomized comparative study of vonoprazan vs esomeprazole -
Title of the study (Brief title)	Study of symptom improvement effect of vonoprazan and esomeprazole in reflux esophagitis patients
Region	Japan

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

Objectives
Narrative objectives1	To compare the clinical effect of vonoprazan 20mg/day vs. esomeprazole 20mg/day after 4 weeks of treatment in patients with reflux esophagitis using Gerd Q score of heartburn and acid regurgitation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gerd Q total score of heartburn and acid regurgitation
Key secondary outcomes	1.Gerd Q each score of heartburn and acid regurgitation 2.Gerd Q each score of epigastralgia, nausea and vomiting 3.Evaluation of treatment response with Gerd Q

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 orally once a day for 4 weeks
Interventions/Control_2	Esomeprazole 20mg orally once a day for 4 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 aged 20 years or older at the time of providing informed consent 2.Patients who are diagnosed as having reflux esophagitis by physician 3.Patients who check 2-3days or 4-7 days a week in GerdQ Q1 and/or Q2
Key exclusion criteria	1.Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), and sudden weight loss 2.Patients confirmed or suspected malignant lesion 3.Patients with a history of gastrointestinal resection or vagotomy 4.Patients in Irritable Bowel Syndrome 5.Patients whose participation in this study would be contraindicated due to complications such as serious hepatic disease, renal disease, or cardiac disease. 6.Women who are pregnant or who may possibly be pregnant, and lactating mothers 7.Other patients whom the investigator considers unsuitable for admission to the study
Target sample size	40

Research contact person
Name of lead principal investigator	Satoshi Maeda
Organization	Sapporo-kosei General Hospital
Division name	Department of Gastroenterology
Address	5, Higashi 8-chome, Kita-3jo, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	+81-11-261-5331
Email	sat.maeda@ja-hokkaidoukouseiren.or.jp

Public contact
Name of contact person	Yohei Terakado
Organization	Sapporo-kosei General Hospital
Division name	Department of Gastroenterology
Address	5, Higashi 8-chome, Kita-3jo, Chuo-ku, Sapporo, Hokkaido, Japan
TEL	+81-11-261-5331
Homepage URL
Email	yohei540525@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology, Sapporo-kosei General Hospital
Institute
Department

Funding Source
Organization	None
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	2016 Year 05 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 25 Day
Anticipated trial start date	2016 Year 05 Month 09 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 02 Day
Last modified on	2017 Year 11 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025540