UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005750
Receipt number 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 09:57:46

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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 or person

Institute

Gifu University

Institute

Department

Personal name



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

Value
https://center6.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