UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021010 |
|---|---|
| Receipt number | R000024216 |
| Scientific Title | Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study. |
| Date of disclosure of the study information | 2016/02/14 |
| Last modified on | 2016/07/23 19:16:16 |
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Basic information
Public title
Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Acronym
Effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer
Scientific Title
Clinical study comparing the effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer with PPI : a case controlled study.
Scientific Title:Acronym
Effect of Vonoprazan, on the healing of endoscopic submucosal dissection-derived artificial ulcer
Region
| Japan |
Condition
Condition
Post-ESD(endoscopic submucosal dissection) artificial gastric ulcer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess the effect of treatment for post-ESD ulcers by Vonoprazan at 5weeks at cost equivalent to proton pomp inhibitor(PPI) at 8weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We assessed the rate of decrease in ulcer size and the postoperative bleeding rate
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study subjects were 75 consecutive patients who treated by Vonoplazan (20mg /day, 5week) after endoscopic submucosal dissection(ESD) for early gastric neoplasm from April 2014 to February 2015 at our hospital.
Control subjects were selected from among 870 patients who had treated by PPI(Rabeprazole 20mg/day, 8week) for artificial gastric ulcer after endoscopic submucosal dissection(ESD) from April 2005 to March 2014 at our hospital.
Age-, sex-, the size of ulcer- and Helicobacter pylori infection-matched two control subjects were selected for one case subject(control group).
Key exclusion criteria
Patients who received additional chemotherapy or surgical treatment after endoscopic submucosal dissection(ESD)
Patients who discontinued Vonoprazan due to side effects
Remnant stomach
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenao Ishikawa |
Organization
Kagawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL
087-811-3333
ishikawa5308@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigenao Ishikawa |
Organization
Kagawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
1-2-1 Asahi-machi,Takamatsu, Kagawa, Japan
TEL
087-811-3333
Homepage URL
ishikawa5308@yahoo.co.jp
Sponsor or person
Institute
Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 14 | 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
| 2014 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 28 | Day |
Other
Other related information
The aim of this study was to assess the effect of the Vonoprazan and the PPI for the ulcer healing and the prevention of bleeding after ESD.
The study subjects were consecutive patients who underwent ESD for superficial gastric neoplasm. Comparison objects were 150 patients who were treated by PPI for post-ESD ulcers.We assessed the rate of decrease in ulcer size and the postoperative bleeding rate in the two groups.
This study was case-control study.
Management information
Registered date
| 2016 | Year | 02 | Month | 13 | Day |
Last modified on
| 2016 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024216
| 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 |
