UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022377 |
|---|---|
| Receipt number | R000025764 |
| Scientific Title | A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2016/05/25 |
| Last modified on | 2020/11/30 10:58:20 |
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Basic information
Public title
A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal
dissection
Acronym
A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal
dissection
Scientific Title
A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal
dissection
Scientific Title:Acronym
A randomized controlled trial of Vonoprazan for the healing of artificial ulcers after endoscopic submucosal
dissection
Region
| Japan |
Condition
Condition
gastric tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficancy of administration of Vonoprazan for gastric ESD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ratio of post-ESD scar after 4 weeks of gastric ESD
Key secondary outcomes
redaction ratio of post-ESD ulcer after 4 weeks of gastric ESD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) 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 Fumarate 20 mg
once a day for 26days after ESD
Interventions/Control_2
Lansoprazole 30 mg
once a day for 26days after ESD
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
gastric tumor which meet indication of Gastric ESD
Key exclusion criteria
1) Patient who cannot discontinue medicine such as PPI, H2blocker and gastroprotective for 1 week before ESD
2) Patients with history of surgery that affects gastric-acid secretion
3) Patients with Zollinger-Ellison syndrome
4) Patients cannot start oral administration
5) Patients with a history of allergy to the investigational product
6) Patients with a serious complication of liver failure
7) Patients with a serious complication of renal failure
8) Patients who cannot make their decision
9) Patients in pregnancy or may be pregnant
10) Patients during breastfeeding
11) Patients treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant)
12) Patient taking medicine such as theophylline, tacrolimus hydrate, digoxin, methyldigoxin, itraconazole, Gefitinib, methotrexate, phenytoin, Diazepam
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
041-8512
Address
N15, W7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-716-1161
yshimizu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Shuichi |
| Middle name | |
| Last name | Miyamoto |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
041-8512
Address
N15, W7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-716-1161
Homepage URL
shuichi0210miyamoto@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology Hokkaido University Graduate School of Medicine
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
NA
Address
NA
Tel
NA
NA
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
| 2016 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
146
Results
NA
Results date posted
| 2020 | Year | 11 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
NA
Participant flow
NA
Adverse events
NA
Outcome measures
NA
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 20 | Day |
Last modified on
| 2020 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025764
| Research Plan | |
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| 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 |
