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
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
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
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
