UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018169 |
|---|---|
| Receipt number | R000021048 |
| Scientific Title | Efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma |
| Date of disclosure of the study information | 2015/07/02 |
| Last modified on | 2017/07/02 10:44:21 |
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Basic information
Public title
Efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Acronym
Efficacy of vonoprazan after ESD for gastric neoplasms
Scientific Title
Efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Scientific Title:Acronym
Efficacy of vonoprazan after ESD for gastric neoplasms
Region
| Japan |
Condition
Condition
Gastric adenoma/carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficacy and safety of administration of vonoprazan after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of the stage of scar at 4 weeks after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma (comparison of vonoprazan and esomeprazole as historical control group)
Key secondary outcomes
The diameter of the ulcer at 4 weeks after endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma and relationship between these and patients background or lesion information (comparison of vonoprazan and esomeprazole as historical control group)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma
Key exclusion criteria
Patients evaluated incompetent by doctors in attendance
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Arai |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
Department of Gastroenterology and Nephrology, Graduate School of Medicine, Chiba University (K1), 1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Maruoka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba-ken, 260-8670, Japan
TEL
043-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27492962
Number of participants that the trial has enrolled
Results
Ulcer contraction rate at 4 weeks after ESD in the vonoprazan group was significantly higher than that of the esomeprazole group (97.7 +- 3.2% vs 94.5 +- 6.7%, respectively, P = 0.025), and 100% contraction rate tended to be higher in the vonoprazan group relative to the esomeprazole group (32% vs 13%, respectively, P = 0.070).
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 | 06 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who have undergone endoscopic submucosal dissection (ESD) for gastric adenoma/carcinoma start to be administrated vonoprazan and undergo periodic endoscopy; be measured diameter of ulcer post ESD at 4 weeks after ESD.
Management information
Registered date
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2017 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021048
| 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 |
