UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016642 |
|---|---|
| Receipt number | R000019318 |
| Scientific Title | Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer |
| Date of disclosure of the study information | 2015/02/27 |
| Last modified on | 2020/07/21 19:29:41 |
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Basic information
Public title
Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Acronym
Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Scientific Title
Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Scientific Title:Acronym
Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Region
| Japan |
Condition
Condition
gastric neoplasm
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aimed to evaluate the effectiveness of Vonoprazan in patients with post-ESD gastric ulcer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
improvement of post-operative gastric ulcer
Key secondary outcomes
Rate of post-operative bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.
Interventions/Control_2
We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.
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 with gastric tumors whom concents has been obtained to participate in this study, which has been approved by the ethics committee
Key exclusion criteria
Remnant stomach, administration of antithrombotic agents, non-steroidal anti-inflammatory drugs and steroids, occurrence of complication during ESD, allergy to lansoprazole or vonoprazan, and unwillingness to participate in the study.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Ryuta |
| Middle name | |
| Last name | Takenaka |
Organization
Tsuyama Chuo Hospital
Division name
Department of Gastroenterology
Zip code
708-0841
Address
1756 Kawasaki-Tsuyama-city, Okayama
TEL
0868-21-8111
daicawai@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kawai |
Organization
Tsuyama Chuo Hospital
Division name
Department of Gastroenterology
Zip code
708-0841
Address
1756 Kwasaki-Tsuyama-city, Okayama
TEL
0868-21-8111
Homepage URL
daicawai@yahoo.co.jp
Sponsor or person
Institute
Tsuyama Chuo 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
Tsuyama Chuo Hospital
Address
1756, Kawasaki, Tsuyama City
Tel
0878-21-8111
daicawai@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
A prospective, randomized controlled trial of vonoprazan versus lansoprazole
Publication of results
Partially published
Result
URL related to results and publications
Vonoprazan is not superior to lansoprazole in the healing of artificial gastric ulcer after ESD.
Number of participants that the trial has enrolled
168
Results
A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in Vonoprazan group versus group Lansoprazole (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups.
Results date posted
| 2020 | Year | 06 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 168 patients were analyzed.
Participant flow
Patients with gastric tumors were randomly
assigned to the vonoprazan group or lansoprazole group after ESD.
Adverse events
Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD.
Outcome measures
The 4-week healing rate for artificial ulcer
and the 4-week shrinkage rates
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019318
