UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010188 |
|---|---|
| Receipt number | R000011929 |
| Scientific Title | A prospective study of the effect by the biopsy in the rebamipide medication to the ulcer recovery after the endoscopic submucosal dissection (ESD) to a gastric tumor |
| Date of disclosure of the study information | 2013/03/07 |
| Last modified on | 2013/09/07 09:27:56 |
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Basic information
Public title
A prospective study of the effect by the biopsy in the rebamipide medication to the ulcer recovery after the endoscopic submucosal dissection (ESD) to a gastric tumor
Acronym
A prospective study of the effect by the biopsy in the rebamipide medication to the ulcer recovery after the endoscopic submucosal dissection (ESD) to a gastric tumor
Scientific Title
A prospective study of the effect by the biopsy in the rebamipide medication to the ulcer recovery after the endoscopic submucosal dissection (ESD) to a gastric tumor
Scientific Title:Acronym
A prospective study of the effect by the biopsy in the rebamipide medication to the ulcer recovery after the endoscopic submucosal dissection (ESD) to a gastric tumor
Region
| Japan |
Condition
Condition
gastric tumor lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims at the ability to offer the individual medical treatment optimal for every patient for the promote wounds healing effects by the rebamipide addition medical treatment after an endoscopic submucosal dissection (ESD) by examination and elucidation of the mechanisms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the existence of the promotion of ulcer recovery according to rebamipide additional medication to after endoscopycaltreatment artificial ulcer.
Key secondary outcomes
Effects by proton ponp inhibitor single dose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
evaluations of treatments one week after to the artificial ulcer by endoscopycal treatment,lansoprazole independent medical treatment group
Interventions/Control_2
evaluations of treatments one week after to the artificial ulcer by endoscopycal treatment,lansoprazole+rebamipide medical treatment group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient who is planning enforcement of an endoscopic submucosal dissection (ESD)
Key exclusion criteria
The patient who has taken the antiplatelet agent and the anticoagulant.
The steroid internal use patient to whom ulcer healings rates differs from usual, glycemic control bad diabetics.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | kenshi matsumoto |
Organization
Juntendo University
Division name
gastroenterology
Zip code
Address
2-1-1 hongo bunkyo-ku Tokyo
TEL
03-3813-8111
kmatumo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | kenshi matsumoto |
Organization
juntendo university
Division name
gastroenterology
Zip code
Address
2-1-1 hongo bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
kmatumo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
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
順天堂大学病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 07 | 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
| 2012 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 07 | Day |
Last modified on
| 2013 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011929
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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