UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011296 |
|---|---|
| Receipt number | R000013235 |
| Scientific Title | Comparison of an Ecabet Sodium and PPI in the treatment of endoscopic submucosal dissection (ESD)-induced ulcers in early gastric cancer: prospective randomized study |
| Date of disclosure of the study information | 2013/07/29 |
| Last modified on | 2017/01/28 13:06:40 |
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Basic information
Public title
Comparison of an Ecabet Sodium and PPI in the treatment of endoscopic submucosal dissection (ESD)-induced ulcers in early gastric cancer: prospective randomized study
Acronym
The prospective randomized study of ESD-induce ulcer
Scientific Title
Comparison of an Ecabet Sodium and PPI in the treatment of endoscopic submucosal dissection (ESD)-induced ulcers in early gastric cancer: prospective randomized study
Scientific Title:Acronym
The prospective randomized study of ESD-induce ulcer
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Useful of Ecabet Sodium for ESD-induced ulcer in early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endoscopic examination 4 and 8 weeks after ESD
Key secondary outcomes
Clinical symptoms
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
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
8 weeks treatment of Ecabet Sodium 2g t.i.d
Interventions/Control_2
8 weeks treatment of esomeprazole 20mg t.i.d
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
Patients of ESD treatment for early gastric cancer
Key exclusion criteria
Exclusion criteria included patients of other ulcer drugs, or NSAIDs, or aspirin, or anticoagulants, or predonisolone.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenaga Matsui |
Organization
Kinki university hospital
Division name
gastroenterology
Zip code
Address
377-2,ohno-higashi,osakasayama city
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenaga Matsui |
Organization
Kinki university hospital
Division name
gastroenterology
Zip code
Address
377-2,ohno-higashi,osakasayama city
TEL
072-366-0221
Homepage URL
ma2i@med.kindai.ac.jp
Sponsor or person
Institute
Kinki 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
| 2013 | Year | 07 | Month | 29 | 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
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 27 | Day |
Last modified on
| 2017 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013235
