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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017077
Receipt No. R000019811
Scientific Title A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Date of disclosure of the study information 2015/04/08
Last modified on 2016/12/21

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Basic information
Public title A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Acronym A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Scientific Title A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Scientific Title:Acronym A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Region
Japan

Condition
Condition mucosal cancer of the stomach
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the comparative efficacy of vonoprazan and esomeprazole in inducing endoscopic healing of gastric ulcers due to ESD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes A period to cure post ESD ulcer of the stomach.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are 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 vonoprazan 20 mg
Interventions/Control_2 esomeprazole 20 mg
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 were resected gastric mucosal cancer by ESD.
Key exclusion criteria 1.Hypersensitivity of esomeprazole and vonoprzan.
2.Taking medicine which are possible to
interact with vonoprazan or esomeprazole.
3.under pregnancy or breast-feeding.
4.Impossibility of oral intake.
5.Past history of resection of upper GI tract.
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Motoyoshi Izumi
Organization Machida municipal hospital
Division name Department of Gastroenterology
Zip code
Address 2-15-41, Asahimachi, Machida-city, Tokyo
TEL 042-722-2230
Email m.izumi@machida-city-hp.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Motoyoshi Izumi
Organization Machida municipal hospital
Division name Department of Gastroenterology
Zip code
Address 2-15-41, Asahimachi, Machida-city, Tokyo
TEL 0427222230
Homepage URL
Email m.izumi@machida-city-hp.jp

Sponsor
Institute Machida municipal hospital
Institute
Department

Funding Source
Organization Machida municipal 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
2015 Year 04 Month 08 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 Completed
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 09 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2016 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 04 Month 08 Day
Last modified on
2016 Year 12 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019811

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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