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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024002
Receipt No. R000026777
Scientific Title A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers
Date of disclosure of the study information 2016/09/12
Last modified on 2016/09/11

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Basic information
Public title A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in
the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers
Acronym A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in Post ESD gastric ulcer
Scientific Title A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in
the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers
Scientific Title:Acronym A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in Post ESD gastric ulcer
Region
Japan

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

Objectives
Narrative objectives1 Comparison between esomeprazole and rabeprazole of therapetic effect for Post-ESD gastric ulcer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scarring rate of gastric ulcer
Quality of ulcer healing
Complication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Rabeprazole
Interventions/Control_2 Esomeprazole
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
100 years-old >
Gender Male and Female
Key inclusion criteria Gastric neoplasm treated by Clutch Cutter ESD
Single Operater
Patient's agreement
Key exclusion criteria Without above criteria
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya Akahoshi
Organization Aso Iizuka Hospital
Division name Department of Gastroenterology
Zip code
Address Yoshio 3-83, Iizuka city
TEL 0948-22-3800
Email kakahoshi2@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Akahoshi
Organization Aso Iizuka Hospital
Division name Department of Gastroenterology
Zip code
Address Yoshio3-83, Iizuka city
TEL 0948-22-3800
Homepage URL
Email kakahoshi2@aol.com

Sponsor
Institute Aso Iizuka Hospital
Department of Gastroenterology
Institute
Department

Funding Source
Organization Aso Iizuka Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2012 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 11 Day
Last modified on
2016 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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