UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006980
Receipt number R000008234
Scientific Title Under NBI (Narrow Band Imaging) and magnifying endoscopy, study on the usefulness of rebamipide as a pretreatment for improvement of endoscopic view in the gastric mucosa.
Date of disclosure of the study information 2011/12/28
Last modified on 2023/01/08 12:34:48

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Basic information

Public title

Under NBI (Narrow Band Imaging) and magnifying endoscopy, study on the usefulness of rebamipide as a pretreatment for improvement of endoscopic view in the gastric mucosa.

Acronym

The usefulness of rebamipide as a pretreatment for improvement of endoscopic view.

Scientific Title

Under NBI (Narrow Band Imaging) and magnifying endoscopy, study on the usefulness of rebamipide as a pretreatment for improvement of endoscopic view in the gastric mucosa.

Scientific Title:Acronym

The usefulness of rebamipide as a pretreatment for improvement of endoscopic view.

Region

Japan


Condition

Condition

Early gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

A prospective study about rebamipide effect of increased mucus secretion to improve endoscopic view under NBI and magnifying endoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We score mucosal microvascular structure and mucosal microsurface structure under white light imaging and higher magnification endoscopic view at anterior wall of antrum, lesser curvature of lower gastric body,greater curvature of upper gastric body,and then we evaluate the total points of score.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Take 1 tablet of rebamipide three times a day , 9 days before endoscopy.

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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients scheduled for taking endoscopy from whom informed cosent was obtained.

Key exclusion criteria

Post operative stomach

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name nishiyama noriko,mori hirohito

Organization

Kagawa university

Division name

Department of gastroenterology and neurology

Zip code


Address

1750-1 ooaza ikenobe miki town kida country kagawa prefecture

TEL

0878912156

Email



Public contact

Name of contact person

1st name
Middle name
Last name nishiyama noriko

Organization

Kagawa university

Division name

Department of gastroenterology and neurology

Zip code


Address


TEL

0878912156

Homepage URL


Email



Sponsor or person

Institute

Kagawa university

Institute

Department

Personal name



Funding Source

Organization

Kagawa university

Organization

Division

Category of Funding Organization

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 12 Month 28 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

2011 Year 12 Month 28 Day

Date of IRB

2011 Year 12 Month 01 Day

Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date

2013 Year 01 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 12 Month 28 Day

Last modified on

2023 Year 01 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008234


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name