UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019835 |
|---|---|
| Receipt number | R000022911 |
| Scientific Title | A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2019/12/03 11:44:08 |
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Basic information
Public title
A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
Acronym
The efficacy of vonoprazan for ESD-induced ulcer
Scientific Title
A randomised controlled trial to evaluate the efficacy of vonoprazan for artificial ulcer healing after gastric endoscopic submucosal dissection
Scientific Title:Acronym
The efficacy of vonoprazan for ESD-induced ulcer
Region
| Japan |
Condition
Condition
Gastric ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
compare the efficacy of the combined therapy with vonoprazan and rebamipide to lansoprazole and rebamipide for artificial gastric ulcer after endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cure rates of gastric ulcer at 4 weeks after treatment
Key secondary outcomes
Cure rates of gastric ulcer at 8 weeks after treatment, reduction rates of gastric ulcer at 4 and 8 weeks after treatment, incidence rate of delayed 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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan 20mg/day for 4 to 8 weeks p.o.
rebamipide 300mg/day for 4 to 8 weeks p.o.
Interventions/Control_2
lansoprazole 30mg/day for 4 to 8 weeks p.o.
rebamipide 300mg/day for 4 to 8 weeks p.o.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 to 89 who scheduled for ESD for gastric adenoma or early cancer
Key exclusion criteria
Patients with
1)the history of surgery for upper GI
2)concomitant administration of anticoagulants
3)concomitant administration of PPI
4)the history of radiotherapy or chemotherapy within 3 months
5)gastric hyperacidity such as Zollinger-Ellison syndorome
6)allergy to PPI or rebamipide
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Akiyama |
Organization
National Center for Global Health and Medicine
Division name
Gastroenterological medicine
Zip code
Address
1-21-1 toyama,shinjyuku,tokyo
TEL
03-3202-7181
jakiyama.ncgm@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Watanabe |
Organization
National Center for Global Health and Medicine
Division name
Gastroenterological medicine
Zip code
Address
1-21-1 toyama,shinjyuku,tokyo
TEL
03-3202-7181
Homepage URL
kazuw0229@gmail.com
Sponsor or person
Institute
National Center for Global Health and Medicine
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
国立国際医療研究センター
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | 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
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
| 2015 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022911
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
