UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001740 |
|---|---|
| Receipt number | R000002060 |
| Scientific Title | The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial |
| Date of disclosure of the study information | 2009/02/27 |
| Last modified on | 2012/03/06 21:28:39 |
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Basic information
Public title
The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial
Acronym
Rebamipide treatment after ESD
Scientific Title
The healing effect of rebamipide for artificial ulcer after treatment of endoscopic submucosal dissection: a prospective randomized trial
Scientific Title:Acronym
Rebamipide treatment after ESD
Region
| Japan |
Condition
Condition
Early gastric cancer, Gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examination of the healing effect of rebamipide for artificial ulcer after ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The healing ratio of artificial ulcer at 4weeks after ESD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of PPI(proton pump inhibitor) plus rebamipide 300mg for 8weeks
Interventions/Control_2
Administration of PPI for 8weeks after ESD
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 patients of adenocarcinoma and early gastric cancer who receive ESD.
Key exclusion criteria
The patients who: (1)repeat hematemesis, (2) pregnant, (3)has sever liver, renal and cardiopulumonary disease, (4)has allergic drug reaction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Araki, M.D.,Ph.D. |
Organization
Gifu University
Division name
Department of Gastroenterology
Zip code
Address
1-1Yanagito, Gifu city, Gifu prefecture,Japan, 501-1194
TEL
058-230-6308
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu University
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
araara@gifu-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Gifu University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Gifu University
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
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
| 2009 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2008 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 27 | Day |
Last modified on
| 2012 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002060
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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