UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Compare the efficacy of diagnostic treatment with P-CAB and PPI before to do endoscopy for GERD patients.
Title of the study (Brief title)	Compare the efficacy of treatment with P-CAB and PPI in patients with GERD.
Region	Japan

Condition
Condition	Gastroesophageal reflux disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the efficacy of Vonoprazan(20mg/day) vs Esomeprazole(20mg/day) for 1week treatment in patients with GERD by assessing the time(days) to be GERD symptom relief before to do endoscopy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time(days) to GERD symptom relief.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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(Takecab)20mg once a day in the mornimg.
Interventions/Control_2	Esomeprazole(Nexium)20mg once a day in the mornimg.
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 whose chief complain are heartburn or acetic acid more than 2days in a week. 2.Patients who are at least 20 years of age. 3.Patients whose main organs work. 4.Patients who have given written consent to participate in the study.
Key exclusion criteria	1.Patients with a history of hypersensitivity to components of Vonoprazan and Esomeprazole. 2.Patients taking PPI including Vonoprazan and Esomeprazole. 3.Patients taking Atazanavir sulfate and Rilpivirine hydrochloride. 4.Patients who are diagnosed Zollinger-Ellison syndrome and Pernicious anemia. 5.Patients who have complicated other severe diseases and whose clinical trials can not be safety performed or whose effect judgment is difficult. 6.Patients with malignant tumor complications. 7.Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus. 8.Patients who may be pregnant or pregnant. 9.Patients who judged by physician inappropriate to participate in clinical trials.
Target sample size	100

Research contact person
Name of lead principal investigator	Akihiro Tamaki
Organization	Kitasato University
Division name	Internal gastroenterology
Address	1-15-1 Kitasato Minami,Sagamihara,Kanagawa,Japan
TEL	042-778-8111
Email	a.tamaki@kitasato-u.ac.jp

Public contact
Name of contact person	Kengi Ishido
Organization	Kitasato University
Division name	Internal gastroenterology
Address	1-15-1 Kitasato Minami,Sagamihara,Kanagawa,Japan
TEL	042-778-8111
Homepage URL
Email	k.ishido@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
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	2019 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 03 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	2018 Year 12 Month 27 Day
Last modified on	2018 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040313