UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053184 |
|---|---|
| Receipt number | R000060427 |
| Scientific Title | A multicenter prospective cohort study for investigating the visuality of palisade vessels at the gastroesophageal junction (GOJ) after acid secretion inhibitor in patients with reflux esophagitis |
| Date of disclosure of the study information | 2023/12/21 |
| Last modified on | 2024/04/22 21:48:29 |
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Basic information
Public title
A multicenter prospective cohort study for investigating the visuality of palisade vessels at the gastroesophageal junction (GOJ) after acid secretion inhibitor in patients with reflux esophagitis
Acronym
GOJ-P
Scientific Title
A multicenter prospective cohort study for investigating the visuality of palisade vessels at the gastroesophageal junction (GOJ) after acid secretion inhibitor in patients with reflux esophagitis
Scientific Title:Acronym
GOJ-P
Region
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the changes of visuality of palisade vessels at the gastro-oesophageal juntion before and after administration of vonoprazan 20 mg/day for more than four week in patients with reflux esophagitis
Basic objectives2
Others
Basic objectives -Others
observation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement rate of endoscopic score after administration of vonoprazan 20mg/day for more than four weeks
(rate of patients in whom endoscopic score increased more than one after administration of vonoprazan compared with that before administration)
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
1) Patients aged more than 20 years
2) Patients who were diagnosed as reflux esophagitis in the pilot studies
3) Patients who do not take vonoprazan 20mg/day
4) Patients who will take vonoprazan 20mg/day for more than four weeks and will undergo oesophagogastroduodenoscopy after administration of vonoprazan for more than four weeks
5) Patients who enrolled the pilot studies within one month
6) Patients in whom a written consent can be obtained
Key exclusion criteria
1) Patients who do not want to undergo oesophagogastroduodenoscopy
2) Patients who are judged as inappropriate for participating in this study by the researchers
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Uraoka |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511 Japan
TEL
027-220-8148
uraoka@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiko |
| Middle name | |
| Last name | Kuribayashi |
Organization
Gunma University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
371-8511
Address
3-39-15 Showa-machi, Maebashi, Gunma 371-8511 Japan
TEL
0272-220-8137
Homepage URL
shikokuri@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
JDDW GOJZ consortium
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
Gunma University Hospital Clinical Research Review Board
Address
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan
Tel
027-220-8740
ciru_hitotaisho-irb@ml.gunma-u.ac.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
| 2023 | Year | 12 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is an exploratory study. The sample size was estimated as 80 based on number of patients in pilot studies and prevalence of reflux esophagitis.
Management information
Registered date
| 2023 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060427
| 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 |
