UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024002 |
|---|---|
| Receipt number | R000026777 |
| Scientific Title | A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2016/09/11 09:51:13 |
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Basic information
Public title
A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in
the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers
Acronym
A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in Post ESD gastric ulcer
Scientific Title
A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in
the Treatment of Post-Endoscopic Submucosal Dissection Gastric Ulcers
Scientific Title:Acronym
A Randomized Controlled Trial Comparing Rabeprazol with Esomeprazol in Post ESD gastric ulcer
Region
| Japan |
Condition
Condition
early gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison between esomeprazole and rabeprazole of therapetic effect for Post-ESD gastric ulcer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scarring rate of gastric ulcer
Quality of ulcer healing
Complication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Rabeprazole
Interventions/Control_2
Esomeprazole
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Gastric neoplasm treated by Clutch Cutter ESD
Single Operater
Patient's agreement
Key exclusion criteria
Without above criteria
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Akahoshi |
Organization
Aso Iizuka Hospital
Division name
Department of Gastroenterology
Zip code
Address
Yoshio 3-83, Iizuka city
TEL
0948-22-3800
kakahoshi2@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Akahoshi |
Organization
Aso Iizuka Hospital
Division name
Department of Gastroenterology
Zip code
Address
Yoshio3-83, Iizuka city
TEL
0948-22-3800
Homepage URL
kakahoshi2@aol.com
Sponsor or person
Institute
Aso Iizuka Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Aso Iizuka Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2012 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 21 | 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
| 2016 | Year | 09 | Month | 11 | Day |
Last modified on
| 2016 | 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=R000026777
