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Esomeprazole 20mg vs 40mg, Difference of Artificial Ulcer healing rate after Endoscopic Submucosal Dissection.

Status Approved

First Submitted Date

2018/04/30
Registered Date

2018/05/18
Last Updated Date

2018/05/18

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002885
Unique Protocol ID	04-2017-013
Public/Brief Title	Esomeprazole 20mg vs 40mg, Difference of Artificial Ulcer healing rate after Endoscopic Submucosal Dissection.
Scientific Title	Esomeprazole 20mg vs 40mg, Difference of Artificial Ulcer healing rate after Endoscopic Submucosal Dissection.
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	04-2017-013
Approval Date	2017-07-03
Institutional Review Board Name	Pusan National University Yangsan Hospital Institutional Review Board
Institutional Review Board Address	20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
Institutional Review Board Telephone	055-360-3854
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Dae Hwan Kang
Title	M.D. Ph. D.
Telephone	+82-55-360-1535
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, Korea, 50612
Contact Person for Public Queries
Name	Su Jin Kim
Title	M.D., Ph. D.
Telephone	+82-55-360-1535
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, Korea, 50612
Contact Person for Updating Information
Name	Su Jin Kim
Title	M.D.,Ph. D.
Telephone	+82-55-360-1535
Affiliation	Pusan National University Yangsan Hospital
Address	Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do, Korea, 50612

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2017-07-04 Actual
Target Number of Participant	200
Primary Completion Date	2017-12-31 , Actual
Study Completion Date	2017-12-31 , Actual
Name of Study	Pusan National University Yangsan Hospital
Recruitment Status	Completed
Date of First Enrollment	2017-07-04 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Pusan National University Yangsan Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Pusan National University Yangsan Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Endoscopic submucosal dissection(ESD) is a standard procedure for managing gastric neoplasms. Meanwhile, ESD induces larger artificial ulcers to a greater extent than other mucosal resection methods. Recently, several studies have reported that vonoprazan, a novel potassium-competitive acid blocker, is superior compared to proton pump inhibitors (PPIs) for healing artificial ulcers, due to higher acid-inhibitory effects. The aim of this study is to evaluate the effect of stronger acids suppression via doubled dose of PPI on ESD ulcer. Therefore, we compared the effect of 20 mg (standard-dose) and 40 mg (doubled-dose) esomeprazole in terms of ulcer healing.

Study Summary Information

Lay Summary

Endoscopic submucosal dissection(ESD)  is a standard procedure for managing gastric neoplasms. Meanwhile, ESD induces larger artificial ulcers to a greater extent than other mucosal resection methods. Recently, several studies have reported that vonoprazan, a novel potassium-competitive acid blocker, is superior compared to proton pump inhibitors (PPIs) for healing artificial ulcers, due to higher acid-inhibitory effects. The aim of this study is to evaluate the effect of stronger acids suppression via doubled dose of PPI on ESD ulcer. Therefore, we compared the effect of 20 mg (standard-dose) and 40 mg (doubled-dose) esomeprazole in terms of ulcer healing.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Phase4
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug, /Procedure/Surgery
Intervention Description	After endoscopic submucosal dissection, the size of the ulcer was compared between the two groups after oral administration of esomeprazole 20 mg and 40 mg once a day.
Number of Arms	2
Arm 1	Arm Label Esomeprazole 20 mg administered group
	Target Number of Participant 100
	Arm Type Active comparator
	Arm Description Esomeprazole 20 mg was administered once a day after endoscopic submucosal dissection, and the size of the first ulcer after 4 weeks and the size of the ulcer after 4 weeks were compared.
Arm 2	Arm Label Esomeprazole 40 mg administered group
	Target Number of Participant 100
	Arm Type Experimental
	Arm Description Esomeprazole 40 mg was administered once a day after endoscopic submucosal dissection, and the size of the first ulcer after 4 weeks and the size of the ulcer after 4 weeks were compared.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (C00-D48)Neoplasms (C16.99)Malignant neoplasm of stomach, unspecified, unspecified
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 18Year~No Limit
	Description Patients who underwent submucosal dissection of gastric neoplasms over 18 years of age who visited Pusan National University Yangsan Hospital.
Exclusion Criteria	We excluded the following cases: 1. In the case of under the age of 18 2. In the case of refusal of participation 3. In case of delayed bleeding after procedure 4. In the case of operation after the endoscopic submucosal dissection due to non-curative resection
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	clinical-equivalence
Outcome	ulcer contraction rate
Timepoint	Immediately after the procedure and 4 weeks after the procedure
Secondary Outcome(s) 1
Outcome	Percentage of ulcers turning into scars after 4 weeks
Timepoint	Four weeks after the procedure

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	Not provided at time of Registration

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