UMIN-CTR Clinical Trial

Basic information
Public title	A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
Acronym	The efficacy of vonoprazan for ESD-induced ulcer
Scientific Title	A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
Scientific Title:Acronym	The efficacy of vonoprazan for ESD-induced ulcer
Region	Japan

Condition
Condition	Gastric ulcer
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	compare the efficacy of the combined therapy with vonoprazan and rebamipide to lansoprazole and rebamipide for artificial gastric ulcer after endoscopic submucosal dissection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Cure rates of gastric ulcer at 4 weeks after treatment
Key secondary outcomes	Cure rates of gastric ulcer at 8 weeks after treatment, reduction rates of gastric ulcer at 4 and 8 weeks after treatment, incidence rate of delayed bleeding

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	vonoprazan 20mg/day for 4 to 8 weeks p.o. rebamipide 300mg/day for 4 to 8 weeks p.o.
Interventions/Control_2	lansoprazole 30mg/day for 4 to 8 weeks p.o. rebamipide 300mg/day for 4 to 8 weeks p.o.
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Patients aged 20 to 89 who scheduled for ESD for gastric adenoma or early cancer
Key exclusion criteria	Patients with 1)the history of surgery for upper GI 2)concomitant administration of anticoagulants 3)concomitant administration of PPI 4)the history of radiotherapy or chemotherapy within 3 months 5)gastric hyperacidity such as Zollinger-Ellison syndorome 6)allergy to PPI or rebamipide
Target sample size	130

Research contact person
Name of lead principal investigator	1st name Middle name Last name Junichi Akiyama
Organization	National Center for Global Health and Medicine
Division name	Gastroenterological medicine
Zip code
Address	1-21-1 toyama,shinjyuku,tokyo
TEL	03-3202-7181
Email	jakiyama.ncgm@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Kazuhiro Watanabe
Organization	National Center for Global Health and Medicine
Division name	Gastroenterological medicine
Zip code
Address	1-21-1 toyama,shinjyuku,tokyo
TEL	03-3202-7181
Homepage URL
Email	kazuw0229@gmail.com

Sponsor
Institute	National Center for Global Health and Medicine
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	国立国際医療研究センター

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 07 Month 13 Day
Date of IRB	2015 Year 07 Month 13 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 18 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022911