UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007435
Receipt number R000008761
Scientific Title The study for the efficacy of the combine therapy with proton pump inhibitor and rebamipide for the post-endoscopic submucosal dissection (ESD) gastric ulcer
Date of disclosure of the study information 2012/03/05
Last modified on 2012/03/03 03:15:51

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Basic information

Public title

The study for the efficacy of the combine therapy with proton pump inhibitor and rebamipide for the post-endoscopic submucosal dissection (ESD) gastric ulcer

Acronym

The combined therapy with proton pump inhibitor and rebamipide for post-ESD gastric ulcer

Scientific Title

The study for the efficacy of the combine therapy with proton pump inhibitor and rebamipide for the post-endoscopic submucosal dissection (ESD) gastric ulcer

Scientific Title:Acronym

The combined therapy with proton pump inhibitor and rebamipide for post-ESD gastric ulcer

Region

Japan


Condition

Condition

gastric ulcer

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To clarify the efficacy of the combined therapy with proton pump inhibitor and rebamipide for the artificial gastric ulcer after endoscopic submucosal dissection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Cure rates of gastric ulcer at 4 and 8 weeks of the treatment

Key secondary outcomes

safety, influence of CYP2C19 genetic polymorphism, incidence of metachronous gastric cancer


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

rabeprazole 10mg/day for 8 weeks p.o.

Interventions/Control_2

rabeprazole 10mg/day p.o. for 8 weeks
rebamipide 300mg/day p.o. for one year

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 with early gastric cancer or gastric adenoma which were en bloc resected by endoscopic submucosal dissection

Key exclusion criteria

(1) Pregnant, possible pregnant, breast-feeding women
(2) Patients with allergy for the test drugs
(3) Patients with serious complications
(4) Patients who are taking NSAIDs including COX-2 selective inhibitors, low dose aspirin and steroids
(5) When gastric neoplasms are resected in a piecemeal fashion
(6) When further treatment such as second ESD or surgery is required after the first ESD

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Nakamura

Organization

Kyushu University

Division name

Department of Medicine and Bioregulatory Science

Zip code


Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuhiko Nakamura

Organization

Kyushu University

Division name

Department of Medicine and Bioregulatory Science

Zip code


Address


TEL

092-642-5286

Homepage URL


Email



Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



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

2012 Year 03 Month 05 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

Enrolling by invitation

Date of protocol fixation

2010 Year 06 Month 14 Day

Date of IRB


Anticipated trial start date

2010 Year 07 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

2012 Year 03 Month 03 Day

Last modified on

2012 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008761


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name