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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003001
Receipt No. R000003636
Scientific Title The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Date of disclosure of the study information 2010/01/09
Last modified on 2010/01/08

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Basic information
Public title The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Acronym The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Scientific Title The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Scientific Title:Acronym The evaluation of healing effect of Rebamipide for patients with artificial ulcer after ESD
Region
Japan

Condition
Condition early gastric cancers treated by ESD
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of a combination of rebamipide and PPI in comparison to PPI alone on artificial ulcer healing after ESD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The progressing ratio to the Scar-stage and ulcer residual ratio between 2 and 56 days after ESD compared with the PPI and the combination group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The PPI group administered with rabeprazole 20mg daily for 8 weeks
Interventions/Control_2 The combination group administered rebamipide 300mg daily for 8 weeks with rabeprazole 20mg daily.
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
85 years-old >
Gender Male and Female
Key inclusion criteria differenciated gastric cancers with no lymphatic -vascular involvement corrlating with a normal risk of lymph node metastasis were defined as: mucosal cancer without ulcer findings irrespective of tumor size; mucosal cancer with ulcer findings less than 30mm in diameter
Key exclusion criteria EGCs which did not fall into one of the categories were excluded from the study and the patients were urged to receive a gastrectomy with removal of lymph nodes.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Azuma
Organization Kobe University, School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-5-1, kusunoki-cho,chuo-ku, Kobe city
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Kobe University, School of Medicine
Division name Institutional Review Board
Zip code
Address
TEL 078-382-6669
Homepage URL
Email

Sponsor
Institute Kobe University, School of Medicine
Institute
Department

Funding Source
Organization Kobe University, School of Medicine
Organization
Division
Category of Funding Organization Other
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
2010 Year 01 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2006 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2006 Year 10 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
2010 Year 01 Month 08 Day
Last modified on
2010 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003636

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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