UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016835 |
|---|---|
| Receipt number | R000019537 |
| Scientific Title | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/03/18 |
| Last modified on | 2017/08/31 14:57:03 |
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Basic information
Public title
Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Acronym
Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Scientific Title
Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Scientific Title:Acronym
Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the reduction rate in artificial ulcers after endoscopic submucosal dissection between a PPI group and a P-CAB group at random.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction of the size of the gastric ulcer after ESD
Key secondary outcomes
Rate of post-operative bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan fumarate20mg+rebamipide300mg
Interventions/Control_2
esomeprazole20mg+rebamipide300mg
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 who undergo ESD for gastric cancer or gastric adenoma.
Patients who give a written informed consent.
Key exclusion criteria
Pregnancy or lactation.
Past history of allergy for the drugs used in this therapy.
Patients on some form of antithrombotic therapy or NSAIDs, adrenocorticosteroid.
Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction.
Patients who are disqualified for the study by physicians.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Maeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
0452615656
smaeda@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuaki Ishii |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-261-5656
Homepage URL
t146009d@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
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
| 2015 | Year | 03 | Month | 18 | 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
In the healing of artificial ulcer after gastric ESD, both P - CAB and PPI worked well, and no significant difference was found between the differences.
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
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 18 | Day |
Last modified on
| 2017 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019537
| 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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