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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016835
Receipt No. R000019537
Scientific Title Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Date of disclosure of the study information 2015/03/18
Last modified on 2017/08/31

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Basic information
Public title Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Acronym Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Scientific Title Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Scientific Title:Acronym Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Region
Japan

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

Objectives
Narrative objectives1 To compare the reduction rate in artificial ulcers after endoscopic submucosal dissection between a PPI group and a P-CAB group at random.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reduction of the size of the gastric ulcer after ESD
Key secondary outcomes Rate of post-operative bleeding

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 vonoprazan fumarate20mg+rebamipide300mg
Interventions/Control_2 esomeprazole20mg+rebamipide300mg
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 Patients who undergo ESD for gastric cancer or gastric adenoma.
Patients who give a written informed consent.
Key exclusion criteria Pregnancy or lactation.
Past history of allergy for the drugs used in this therapy.
Patients on some form of antithrombotic therapy or NSAIDs, adrenocorticosteroid.
Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction.
Patients who are disqualified for the study by physicians.
Target sample size 72

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shin Maeda
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 0452615656
Email smaeda@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuaki Ishii
Organization Yokohama City University Hospital
Division name Gastroenterology
Zip code
Address Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-261-5656
Homepage URL
Email t146009d@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City 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
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
2015 Year 03 Month 18 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
In the healing of artificial ulcer after gastric ESD, both P - CAB and PPI worked well, and no significant difference was found between the differences.
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
2015 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 18 Day
Last follow-up date
2017 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2017 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 18 Day
Last modified on
2017 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019537

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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