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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005750
Receipt No. R000006801
Scientific Title A study to evaluate the duration of omeprazole treatment for gastric artificial ulcer after ESD
Date of disclosure of the study information 2011/06/13
Last modified on 2011/06/10

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Basic information
Public title A study to evaluate the duration of omeprazole treatment for gastric artificial ulcer after ESD
Acronym A study to evaluate the duration of omeprazole treatment for gastric artificial ulcer after ESD
Scientific Title A study to evaluate the duration of omeprazole treatment for gastric artificial ulcer after ESD
Scientific Title:Acronym A study to evaluate the duration of omeprazole treatment for gastric artificial ulcer after ESD
Region
Japan

Condition
Condition Patients who underwent ESD for the treatment of gastorointestinal stromal tumor (no less than 20 years old)
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the relationship between duration of omeprazole treatment after ESD, relief of symptoms, healing process of gastric ulcer, and QOL
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes tumor volume, tumor stage, gastrointestinal questionnaire, GRSR score
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Omeprazole
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who underwent ESD for the treatment of gastorointestinal stromal tumor
Key exclusion criteria 1) Patients with previous partial gastrectomy or vagotomy
2) Patients receiving anti-coagulants, anti-platelet agents, or steroids
3) Patients with sever cerebral, cardiac, renal, or hematopoietic dysfunction
4) Patients with hypersensitivity to omeprazole
5) Pregnant or lactating women or women who plan to become pregnant during the study
6) Patients who underwent H. pylori eradication after ESD

Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Araki
Organization Gifu University Hospital
Division name Department of Endoscopy
Zip code
Address 1-1 Yanagido,Gifu,Gifu,501-1112
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Gifu University Hospital
Division name Department of Endoscopy
Zip code
Address 1-1 Yanagido,Gifu,Gifu,501-1112
TEL
Homepage URL
Email

Sponsor
Institute Gifu University
Institute
Department

Funding Source
Organization Research fund of The Gifu University Hospital,Department of Endoscopy
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
2011 Year 06 Month 13 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 Open public recruiting
Date of protocol fixation
2011 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 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
2011 Year 06 Month 10 Day
Last modified on
2011 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006801

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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