UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Title of the study (Brief title)	A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Region	Japan

Condition
Condition	early gastric cancer, gastric adenoma
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the healing rate of gastric ulcers induced by endoscopic submucosal dissection(ESD) in response to vonoprazan or esomeprazole administration
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	healing rate and reduction rate of gastric ulcers at 4 and 8 weeks after endoscopic procedure
Key secondary outcomes	frequency of post procedure bleeding

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is 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 fumarate20mg plus rebamipide300mg/day
Interventions/Control_2	esomeprazole20mg plus rebamipide300mg/day
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 will undergo ESD for early gastric cancer or adenoma at Tsuchiura kyodo hospital. Patients with written informed consent.
Key exclusion criteria	Patients with the possibility of the pregnancy or the pregnancy Patients who are lactating Patients with allergy for the drugs in this trial Patients with severe liver dysfunction, or heart dysfunction Patients with perforation during ESD Patients who are disqualified for this study by physicians
Target sample size	85

Research contact person
Name of lead principal investigator	Yoshinori Sakai
Organization	Tsuchiura Kyodo General Hospital
Division name	Department of gastroenterology
Address	11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL	029-823-3111
Email	sakai@tkgh.jp

Public contact
Name of contact person	Takashi Ichida
Organization	Tsuchiura Kyodo General Hospital
Division name	Department of gastroenterology
Address	11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL	029-823-3111
Homepage URL
Email	taka_taka_0621@yahoo.co.jp

Sponsor
Institute	Tsuchiura Kyodo General Hospital
Institute
Department

Funding Source
Organization	Tsuchiura Kyodo General 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	土浦協同病院

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 18 Day
Anticipated trial start date	2015 Year 10 Month 27 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 27 Day
Last modified on	2018 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022573