UMIN-CTR Clinical Trial

Basic information
Public title	Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Acronym	Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Scientific Title	Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Scientific Title:Acronym	Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to assess the rate of post ESD bleeding and post ESD perforation.We administer vonoprazan for 8 weeks to the patients who ESD was performed.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Post ESD bleeding rate of the patient who ESD was perfomed.
Key secondary outcomes	Post ESD perforation rate of the patient who ESD was perfomed.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Vonoprazan administration(20mg, 8weeks)
Interventions/Control_2
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	The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.
Key exclusion criteria	1) The patients on antithrombotic therapy. 2) The patients on dialysis. 3) The patients with a history of allergy to vonoprazan. 4) The patients on administration of atazanavir or rilpivirine. 5) Those who are considered to be inappropriate for this study by doctors.
Target sample size	115

Research contact person
Name of lead principal investigator	1st name Taro Middle name Last name Akashi
Organization	Nagasaki University Hospital
Division name	Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code	852-8501
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7481
Email	fuk.naga.23@gmail.com

Public contact
Name of contact person	1st name Taro Middle name Last name Akashi
Organization	Nagasaki University Hospital
Division name	Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code	852-8501
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7481
Homepage URL
Email	fuk.naga.23@gmail.com

Sponsor
Institute	Nagasaki 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)

IRB Contact (For public release)
Organization	Nagasaki University Hospital General Affairs Division
Address	1-7-1 Sakamoto,Nagasaki
Tel	095-819-7217
Email	mh-shomu@ml.nagasaki-u.ac.jp

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	長崎大学病院（長崎県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 10 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	2016 Year 02 Month 24 Day
Date of IRB	2016 Year 03 Month 24 Day
Anticipated trial start date	2016 Year 04 Month 11 Day
Last follow-up date	2018 Year 05 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 03 Day
Last modified on	2022 Year 09 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026001