UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028502 |
|---|---|
| Receipt number | R000032552 |
| Scientific Title | Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients -Randomized controlled comparative test of vonoprazan and esomeprazole- |
| Date of disclosure of the study information | 2017/08/04 |
| Last modified on | 2019/06/04 15:35:03 |
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Basic information
Public title
Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
-Randomized controlled comparative test of vonoprazan and esomeprazole-
Acronym
Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Scientific Title
Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
-Randomized controlled comparative test of vonoprazan and esomeprazole-
Scientific Title:Acronym
Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Region
| Japan |
Condition
Condition
Reflux esophagitis patients
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The symptom improvement effect and endoscopic improvement of gastric acid secretion inhibitors for reflux esophagitis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Consideration of the symptom improvement value using the interview sheet after4,8 week treatment and the endoscopic improvement effect of after 8 week treatment
Key secondary outcomes
The safety value of the treatment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonopurazan 20mg P.o.once daily,8weeks
Interventions/Control_2
Esomeprazole 20mg P.o.once daily,8weeks
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
1.Patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation.
2.Patients who were confirmed reflux esophagitis with grade A-D of LA classification at the entry.
Key exclusion criteria
1.Patients with a history of gastrointestinal resection or vagotomy.
2.Patients with confirmed or susupected malignant disease.
3.Pregnancy or lactation.
4.Past history of allergy for the drugs used in this therapy.
5.Ptients with sever liver dysfunction,sever renal dysfunction,sever hert dysfunction.
6.Ptients who are disqualifid for the study by physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Syuji Inoue |
Organization
National Hospital Organization National Kochi Hospital
Division name
gastroenterology
Zip code
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL
088-844-3111
inouesh@kochi2.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Inoue/Sizuka Eguthi |
Organization
National Hospital Organization National Kochi Hospital
Division name
gastroenterology
Zip code
Address
1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL
088-844-3111
Homepage URL
inouesh@kochi2.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization National Kochi Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization National Kochi 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
独立行政法人国立病院機構高知病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2017 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032552
| 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 |
