UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the healing effect of Vonoprazan and Lansoprazole in ulcer after gastric endoscopic submucosal dissection: A prospective, randomized controlled trial
Title of the study (Brief title)	Vonoprazan ESD study
Region	Japan

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

Objectives
Narrative objectives1	comparison of Vonoprazan Fumarate and Lansoprazole for efficacy and safety on four and eight weeks administration after ESD of gastric tumor
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gastric ulcer healing rate of post-ESD ulcers after four and eight weeks of gastric ESD
Key secondary outcomes	postoperative bleeding rate after four and eight weeks of gastric ESD

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) 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 Fumarate
Interventions/Control_2	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	Not applicable
Gender	Male and Female
Key inclusion criteria	gastric tumor which meet indication of Gastric Cancer Treatment Guidelines 2014
Key exclusion criteria	1) Patients with difficulty in drug dosing or endoscope insertion due to a stricture or deformity in the upper gastrointestinal tract 2) Patients with an active malignant tumor or other serious systemic complications 3) Patients concurrently treated with an antithrombotic drug 4) Patients with an active ulcer 5) Patients having a problem with their hemostatic ability 6) Patients with a serious complication (heart failure, renal failure, liver failure, respiratory failure) 7) Patients undergoing dialysis 8) Patients with a history of allergy to the investigational product 9) Patients treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant) 10) Patients in pregnancy or lactation 11) Having a previous history of irradiation to the upper abdomen 12) Scheduled to concurrently receive endoscopic therapy for both esophageal and duodenal lesions 13) Having a history of enrollment in this trial 14) Patients whose consent to participate in this clinical study has not been obtained 15) Other patients judged to be inappropriate as a subject by the principal investigator or a subinvestigator
Target sample size	124

Research contact person
Name of lead principal investigator	Higuchi Kazuhide
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL	072-683-1221
Email	higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person	Toshihisa Takeuchi
Organization	Osaka Medical College
Division name	Second Department of Internal Medicine
Address	2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL	072-683-1221
Homepage URL
Email	in2097@poh.osaka-med.ac.jp

Sponsor
Institute	Osaka Medical College
Institute
Department

Funding Source
Organization	Osaka Medical College, Second Department of Internal Medicine
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 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 02 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 31 Day
Date analysis concluded	2017 Year 08 Month 31 Day

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

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2017 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019351