UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparative study of Potassium Competitive acid blocker (P-CAB) and Classic proton pomp inhibitor in clinical effectiveness for gastro-esophageal reflux symptoms :Randomized Comparative study of venoprazan and esomeprazole
Title of the study (Brief title)	Comparative study of venoprazan and esomeprazol in clinical effectiveness for gastro-esophageal reflux symptoms.
Region	Japan

Condition
Condition	Patients of gastro-esophageal reflux symptoms
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We evaluate the clinical effectiveness of P-CAB compared with classical PPI in GERD patients, who are administered venoprazan 20mg/day or esomeprazole 20mg/day.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	The clinical improvement of GERD symptoms (heartburn, acid reflux) evaluated using self-assessment interview sheet, GerdQ, 4 weeks after treatment.
Key secondary outcomes	i) The early efficacy of medication, on 1,3,7 day after treatment. ii) The incidence of side effects.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are 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 in the evning, 4weeks
Interventions/Control_2	Esomeprazole 20mg oral once a day in the evning, 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	i) The patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation. ii) The patients with heartburn and/or acid reflux during 2-3days/week or 4-7days/week in GerdQ.
Key exclusion criteria	i) The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss. ii) The patients with confirmed or suspected malignant diseases. iii) The patients with a history of gastrointestinal resection of vagotomy. iv) The patients with a history of irritable bowel syndrome. v) The patients whose participation in this study would be contraindicated due to complications such as serious heaptic, renal or heart disease. vi) The Pregnant patients or possibly pregnant patients. vii) The patients prohibited the participant of this study by their attending physicians.
Target sample size	60

Research contact person
Name of lead principal investigator	Kouichi Sakurai
Organization	Hattori clinic
Division name	Hattori clinic
Address	2-12-35 Shinmachi, Tyuuouku, Kumamoto City, Kumamoto 860-0047
TEL	096-325-2300
Email	sakurai@s3.kcn-tv.ne.jp

Public contact
Name of contact person	Kouichi Sakurai
Organization	Hattori clinic
Division name	Hattori clinic
Address	2-12-35 Shinmachi, Tyuuouku, Kumamoto City, Kumamoto 860-0047
TEL	096-325-2300
Homepage URL
Email	sakurai@s3.kcn-tv.ne.jp

Sponsor
Institute	Hattori clinic
Institute
Department

Funding Source
Organization	others
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	熊本服部胃腸科

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 02 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 02 Day
Last follow-up date	2017 Year 07 Month 31 Day
Date of closure to data entry	2017 Year 07 Month 31 Day
Date trial data considered complete	2017 Year 07 Month 31 Day
Date analysis concluded

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

Management information
Registered date	2016 Year 04 Month 02 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025085