UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018356 |
|---|---|
| Receipt number | R000019978 |
| Scientific Title | Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2017/01/20 16:23:11 |
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Basic information
Public title
Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Acronym
Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Scientific Title
Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Scientific Title:Acronym
Effect of Vonoprazan for postoperative ulcer healing of gastric endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
superficial gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluating the effect of Vonoprazan for postoperative ulcer healing of gastric ESD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative ulcer reduction rate of gastric ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prescription of Vonoprazan
Interventions/Control_2
prescription of Lansoprazole
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
expanded criteria for gastric ESD
Key exclusion criteria
Patients who
1) had a history of prior surgery
2) had lesions with severe submucosal fibrosis
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Horikawa |
Organization
Hiraka General Hospital
Division name
Gastroenterology
Zip code
Address
Maego, Yatsukuchi, 3-1, Yokote city
TEL
0182-32-5121
horikawa_01@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunio Nagasawa |
Organization
Akita Rural Medical Research Center
Division name
Research Center
Zip code
Address
Maego, Yatsukuchi, 3-1, Yokote city
TEL
0182-32-5121
Homepage URL
horikawa_01@me.com
Sponsor or person
Institute
Hiraka General Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | 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 | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | 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 | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
