UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Title of the study (Brief title)	A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Region	Japan

Condition
Condition	mucosal cancer of the stomach
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the comparative efficacy of vonoprazan and esomeprazole in inducing endoscopic healing of gastric ulcers due to ESD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	A period to cure post ESD ulcer of the stomach.
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 20 mg
Interventions/Control_2	esomeprazole 20 mg
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	Patients who were resected gastric mucosal cancer by ESD.
Key exclusion criteria	1.Hypersensitivity of esomeprazole and vonoprzan. 2.Taking medicine which are possible to interact with vonoprazan or esomeprazole. 3.under pregnancy or breast-feeding. 4.Impossibility of oral intake. 5.Past history of resection of upper GI tract.
Target sample size	80

Research contact person
Name of lead principal investigator	Motoyoshi Izumi
Organization	Machida municipal hospital
Division name	Department of Gastroenterology
Address	2-15-41, Asahimachi, Machida-city, Tokyo
TEL	042-722-2230
Email	m.izumi@machida-city-hp.jp

Public contact
Name of contact person	Motoyoshi Izumi
Organization	Machida municipal hospital
Division name	Department of Gastroenterology
Address	2-15-41, Asahimachi, Machida-city, Tokyo
TEL	0427222230
Homepage URL
Email	m.izumi@machida-city-hp.jp

Sponsor
Institute	Machida municipal hospital
Institute
Department

Funding Source
Organization	Machida municipal hospital
Organization
Division
Category of Funding Organization	Other
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	2015 Year 04 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 31 Day
Anticipated trial start date	2015 Year 04 Month 09 Day
Last follow-up date	2016 Year 12 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2016 Year 12 Month 01 Day

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

Management information
Registered date	2015 Year 04 Month 08 Day
Last modified on	2016 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019811