UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018188 |
|---|---|
| Receipt number | R000021063 |
| Scientific Title | Healing effect of a Vonoprazan or a Lansoprazole for artificial ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. |
| Date of disclosure of the study information | 2015/07/07 |
| Last modified on | 2018/01/05 17:07:42 |
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Basic information
Public title
Healing effect of a Vonoprazan or a Lansoprazole for artificial ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial.
Acronym
Healing effect of P-CAB for artificial ulcer after ESD.
Scientific Title
Healing effect of a Vonoprazan or a Lansoprazole for artificial ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial.
Scientific Title:Acronym
Healing effect of P-CAB for artificial ulcer after ESD.
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
It is aimed for the decision of appropriate gastric secretion inhibitors for artificial ulcer after endoscopic submucosal dissection in consideration of the CYP2C19 polymorphism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The healing rate of artificial ulcer after endoscopic submucosal dissection is evaluated.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Eradication of H. pylori before ESD.
Vonoprazan is given after ESD.
Interventions/Control_2
Eradication of H. pylori before ESD.
Lansoprazole is given after ESD.
Interventions/Control_3
No eradication of H. pylori before ESD.
Vonoprazan is given after ESD.
Interventions/Control_4
No eradication of H. pylori before ESD.
Lansoprazole is given after ESD.
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
1. A case included in the adaptation of the ESD treatment that followed "stomach cancer treatment guidelines"
2. A case of H.pylori-positive
3. A case of 20 years or older
4. A case that Performance status (ECOG) is 0, 1 or 2
Key exclusion criteria
1. A case that takes steroid more than 15 mg
2. A case having serious complications (heart failure, renal failure, liver failure, respiratory failure)
3. A case to have an allergy career to a study drug
4. A case that it was not agree by the participation in this clinical study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Andoh |
Organization
Shiga University of Medical Science
Division name
Divison of Gastroenterology
Zip code
Address
Seta Tsukinowa-cho ,Otsu, Shiga
TEL
077-548-2217
Andoh@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Ban |
Organization
Shiga University of Medical Science
Division name
Division of Digestive Endoscopy
Zip code
Address
Seta Tsukinowa-cho ,Otsu, Shiga
TEL
077-548-2217
Homepage URL
hban@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
None
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
滋賀医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | 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
| 2015 | Year | 07 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021063
