UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019516 |
|---|---|
| Receipt number | R000022573 |
| Scientific Title | A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection |
| Date of disclosure of the study information | 2015/10/27 |
| Last modified on | 2018/10/29 12:45:34 |
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Basic information
Public title
A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Acronym
A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Scientific Title
A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Scientific Title:Acronym
A randomized controlled trial to compare the effects of vonoprazan and esomeprazole on gastric ulcer healing induced by endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the healing rate of gastric ulcers induced by endoscopic submucosal dissection(ESD) in response to vonoprazan or esomeprazole administration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
healing rate and reduction rate of gastric ulcers at 4 and 8 weeks after endoscopic procedure
Key secondary outcomes
frequency of post procedure bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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 fumarate20mg plus rebamipide300mg/day
Interventions/Control_2
esomeprazole20mg plus rebamipide300mg/day
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 will undergo ESD for early gastric cancer or adenoma at Tsuchiura kyodo hospital.
Patients with written informed consent.
Key exclusion criteria
Patients with the possibility of the pregnancy or the pregnancy
Patients who are lactating
Patients with allergy for the drugs in this trial
Patients with severe liver dysfunction, or heart dysfunction
Patients with perforation during ESD
Patients who are disqualified for this study by physicians
Target sample size
85
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Sakai |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of gastroenterology
Zip code
Address
11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL
029-823-3111
sakai@tkgh.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ichida |
Organization
Tsuchiura Kyodo General Hospital
Division name
Department of gastroenterology
Zip code
Address
11-7 Manabeshin-machi, Tuchiura, Ibaraki
TEL
029-823-3111
Homepage URL
taka_taka_0621@yahoo.co.jp
Sponsor or person
Institute
Tsuchiura Kyodo General Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsuchiura Kyodo General 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
土浦協同病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 09 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | 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 | 10 | Month | 27 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022573
| 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 |
