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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007435
Receipt No. 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

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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
Institute Kyushu University
Institute
Department

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
URL(English) https://upload.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


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