UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Title of the study (Brief title)	Comparison of PPIand P-CAB in the gastric ulcer healing after 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 compare the reduction rate in artificial ulcers after endoscopic submucosal dissection between a PPI group and a P-CAB group at random.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Reduction of the size of the gastric ulcer after ESD
Key secondary outcomes	Rate of post-operative 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	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	vonoprazan fumarate20mg+rebamipide300mg
Interventions/Control_2	esomeprazole20mg+rebamipide300mg
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 undergo ESD for gastric cancer or gastric adenoma. Patients who give a written informed consent.
Key exclusion criteria	Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Patients on some form of antithrombotic therapy or NSAIDs, adrenocorticosteroid. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
Target sample size	72

Research contact person
Name of lead principal investigator	Shin Maeda
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	0452615656
Email	smaeda@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Yasuaki Ishii
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-261-5656
Homepage URL
Email	t146009d@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
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	2015 Year 03 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 18 Day
Anticipated trial start date	2015 Year 03 Month 18 Day
Last follow-up date	2017 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	In the healing of artificial ulcer after gastric ESD, both P - CAB and PPI worked well, and no significant difference was found between the differences.
Other related information

Management information
Registered date	2015 Year 03 Month 18 Day
Last modified on	2017 Year 08 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019537