UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017077 |
|---|---|
| Receipt number | R000019811 |
| Scientific Title | A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer. |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2016/12/21 18:24:27 |
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Basic information
Public title
A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Acronym
A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Scientific Title
A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Scientific Title:Acronym
A randomised, comparative study of vonoprazan and esomeprazole 20mg in the treatment of gastric ulcers due to endoscopic submucosal dissection (ESD) for gastric mucosal cancer.
Region
| Japan |
Condition
Condition
mucosal cancer of the stomach
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the comparative efficacy of vonoprazan and esomeprazole in inducing endoscopic healing of gastric ulcers due to ESD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
A period to cure post ESD ulcer of the stomach.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
vonoprazan 20 mg
Interventions/Control_2
esomeprazole 20 mg
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 were resected gastric mucosal cancer by ESD.
Key exclusion criteria
1.Hypersensitivity of esomeprazole and vonoprzan.
2.Taking medicine which are possible to
interact with vonoprazan or esomeprazole.
3.under pregnancy or breast-feeding.
4.Impossibility of oral intake.
5.Past history of resection of upper GI tract.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahimachi, Machida-city, Tokyo
TEL
042-722-2230
m.izumi@machida-city-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motoyoshi Izumi |
Organization
Machida municipal hospital
Division name
Department of Gastroenterology
Zip code
Address
2-15-41, Asahimachi, Machida-city, Tokyo
TEL
0427222230
Homepage URL
m.izumi@machida-city-hp.jp
Sponsor or person
Institute
Machida municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Machida municipal 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
| 2015 | Year | 04 | Month | 08 | 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
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 08 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019811
| 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 |
