UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022595 |
|---|---|
| Receipt number | R000026001 |
| Scientific Title | Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing |
| Date of disclosure of the study information | 2016/06/10 |
| Last modified on | 2022/09/07 20:25:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Acronym
Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Scientific Title
Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Scientific Title:Acronym
Effect of vonoprazan, a potassium competitive acid blocker, in post endoscopic submucosal dissection ulcer healing
Region
| Japan |
Condition
Condition
early gastric cancer/gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the rate of post ESD bleeding and post ESD perforation.We administer vonoprazan for 8 weeks to the patients who ESD was performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post ESD bleeding rate of the patient who ESD was perfomed.
Key secondary outcomes
Post ESD perforation rate of the patient who ESD was perfomed.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan administration(20mg, 8weeks)
Interventions/Control_2
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
The patients who have given written informed consent to this study, and age at the time of the agreement acquisition is 20 years or older.
Key exclusion criteria
1) The patients on antithrombotic therapy.
2) The patients on dialysis.
3) The patients with a history of allergy to vonoprazan.
4) The patients on administration of atazanavir or rilpivirine.
5) Those who are considered to be inappropriate for this study by doctors.
Target sample size
115
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Akashi |
Organization
Nagasaki University Hospital
Division name
Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code
852-8501
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7481
fuk.naga.23@gmail.com
Public contact
Name of contact person
| 1st name | Taro |
| Middle name | |
| Last name | Akashi |
Organization
Nagasaki University Hospital
Division name
Department of GASTROENTEROLOGY and HEPATOLOGY
Zip code
852-8501
Address
1-7-1 Sakamoto,Nagasaki
TEL
095-819-7481
Homepage URL
fuk.naga.23@gmail.com
Sponsor or person
Institute
Nagasaki 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
Nagasaki University Hospital General Affairs Division
Address
1-7-1 Sakamoto,Nagasaki
Tel
095-819-7217
mh-shomu@ml.nagasaki-u.ac.jp
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
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 10 | 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
| 2016 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 03 | Day |
Last modified on
| 2022 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026001
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
