UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal dissection
Acronym	A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal dissection
Scientific Title	A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal dissection
Scientific Title:Acronym	A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal dissection
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficancy of administration of Vonoprazan for gastric ESD
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ratio of post-ESD scar after 4 weeks of gastric ESD
Key secondary outcomes	redaction ratio of post-ESD ulcer after 4 weeks of gastric ESD

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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 20 mg once a day for 26days after ESD
Interventions/Control_2	Lansoprazole 30 mg once a day for 26days after ESD
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 ESD
Key exclusion criteria	1) Patient who cannot discontinue medicine such as PPI, H2blocker and gastroprotective for 1 week before ESD 2) Patients with history of surgery that affects gastric-acid secretion 3) Patients with Zollinger-Ellison syndrome 4) Patients cannot start oral administration 5) Patients with a history of allergy to the investigational product 6) Patients with a serious complication of liver failure 7) Patients with a serious complication of renal failure 8) Patients who cannot make their decision 9) Patients in pregnancy or may be pregnant 10) Patients during breastfeeding 11) Patients treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant) 12) Patient taking medicine such as theophylline, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, Gefitinib, methotrexate, phenytoin, Diazepam
Target sample size	146

Research contact person
Name of lead principal investigator	1st name Yuichi Middle name Last name Shimizu
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	041-8512
Address	N15, W7, Kita-ku, Sapporo 060-8638, Japan
TEL	011-716-1161
Email	yshimizu@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Shuichi Middle name Last name Miyamoto
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	041-8512
Address	N15, W7, Kita-ku, Sapporo 060-8638, Japan
TEL	011-716-1161
Homepage URL
Email	shuichi0210miyamoto@yahoo.co.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology Hokkaido University Graduate School of Medicine
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	NA
Address	NA
Tel	NA
Email	NA

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	2016 Year 05 Month 25 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	146
Results	NA
Results date posted	2020 Year 11 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NA
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 18 Day
Date of IRB	2016 Year 04 Month 14 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2017 Year 09 Month 01 Day
Date of closure to data entry	2017 Year 09 Month 01 Day
Date trial data considered complete	2017 Year 10 Month 01 Day
Date analysis concluded	2017 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2016 Year 05 Month 20 Day
Last modified on	2020 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025764