UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Title of the study (Brief title)	Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Region	Japan

Condition
Condition	superficial gastric tumor
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluating the effect of Vonoprazan for postoperative ulcer healing of gastric ESD
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	postoperative ulcer reduction rate of gastric ESD
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	prescription of Vonoprazan
Interventions/Control_2	prescription of Lansoprazole
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	95 years-old >
Gender	Male and Female
Key inclusion criteria	expanded criteria for gastric ESD
Key exclusion criteria	Patients who 1) had a history of prior surgery 2) had lesions with severe submucosal fibrosis
Target sample size	40

Research contact person
Name of lead principal investigator	Yohei Horikawa
Organization	Hiraka General Hospital
Division name	Gastroenterology
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Email	horikawa_01@me.com

Public contact
Name of contact person	Kunio Nagasawa
Organization	Akita Rural Medical Research Center
Division name	Research Center
Address	Maego, Yatsukuchi, 3-1, Yokote city
TEL	0182-32-5121
Homepage URL
Email	horikawa_01@me.com

Sponsor
Institute	Hiraka General Hospital
Institute
Department

Funding Source
Organization	None
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 07 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 20 Day
Anticipated trial start date	2015 Year 05 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	2015 Year 07 Month 20 Day
Last modified on	2017 Year 01 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019978