UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011715 |
|---|---|
| Receipt number | R000013696 |
| Scientific Title | A trial of rebamipide for the healing of artificial ulcers after endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2013/09/11 |
| Last modified on | 2013/09/11 20:51:38 |
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Basic information
Public title
A trial of rebamipide for the healing of artificial ulcers after endoscopic submucosal dissection.
Acronym
Rebamipide for artificial ulcers after endoscopic submucosal dissection.
Scientific Title
A trial of rebamipide for the healing of artificial ulcers after endoscopic submucosal dissection.
Scientific Title:Acronym
Rebamipide for artificial ulcers after endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate rebamipide for the healing of artificial ulcers after endoscopic submucosal dissection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of ulcer healing by rebamipide 8 W after ESD.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
omeprazol group
Interventions/Control_2
omepurazol and rebamipide 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20-80 years old
patients for endocopic resection
Key exclusion criteria
Patients with
partial gastrectomy
severe heart disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Nishikawa |
Organization
Ymaguchi University Graduate School of Medicine
Division name
Department of gastroenterology and hepatology
Zip code
Address
1-1-1 Minamikogushi
TEL
0836-22-2241
junnis@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Nishikawa |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of gastroenterology
Zip code
Address
1-1-1 Minamikogushi
TEL
0836-22-2241
Homepage URL
junnis@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi University Graduate School of Medicine
Organization
Division
Category of Funding Organization
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
| 2013 | Year | 09 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 08 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2013 | Year | 09 | Month | 11 | Day |
Last modified on
| 2013 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013696
