UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Title of the study (Brief title)	Effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer
Region	Japan

Condition
Condition	Post-ESD(endoscopic submucosal dissection) artificial gastric ulcer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study was to assess the effect of treatment for post-ESD ulcers by Vonoprazan at 5weeks at cost equivalent to proton pomp inhibitor(PPI) at 8weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	We assessed the rate of decrease in ulcer size and the postoperative bleeding rate
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The study subjects were 75 consecutive patients who treated by Vonoplazan (20mg /day, 5week) after endoscopic submucosal dissection(ESD) for early gastric neoplasm from April 2014 to February 2015 at our hospital. Control subjects were selected from among 870 patients who had treated by PPI(Rabeprazole 20mg/day, 8week) for artificial gastric ulcer after endoscopic submucosal dissection(ESD) from April 2005 to March 2014 at our hospital. Age-, sex-, the size of ulcer- and Helicobacter pylori infection-matched two control subjects were selected for one case subject(control group).
Key exclusion criteria	Patients who received additional chemotherapy or surgical treatment after endoscopic submucosal dissection(ESD) Patients who discontinued Vonoprazan due to side effects Remnant stomach
Target sample size	75

Research contact person
Name of lead principal investigator	Shigenao Ishikawa
Organization	Kagawa Prefectural Central Hospital
Division name	Department of Gastroenterology
Address	1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL	087-811-3333
Email	ishikawa5308@yahoo.co.jp

Public contact
Name of contact person	Shigenao Ishikawa
Organization	Kagawa Prefectural Central Hospital
Division name	Department of Gastroenterology
Address	1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL	087-811-3333
Homepage URL
Email	ishikawa5308@yahoo.co.jp

Sponsor
Institute	Kagawa Prefectural Central Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	none
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

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 02 Month 01 Day
Date trial data considered complete	2016 Year 02 Month 01 Day
Date analysis concluded	2016 Year 02 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	The aim of this study was to assess the effect of the Vonoprazan and the PPI for the ulcer healing and the prevention of bleeding after ESD. The study subjects were consecutive patients who underwent ESD for superficial gastric neoplasm. Comparison objects were 150 patients who were treated by PPI for post-ESD ulcers.We assessed the rate of decrease in ulcer size and the postoperative bleeding rate in the two groups. This study was case-control study.

Management information
Registered date	2016 Year 02 Month 13 Day
Last modified on	2016 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024216