UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028712 |
|---|---|
| Receipt number | R000032866 |
| Scientific Title | The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users. |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2024/02/25 14:55:02 |
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Basic information
Public title
The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users.
Acronym
The assessment of gastric histology in lon-term PPI users.
Scientific Title
The assessment of gastrin level and gastric histology in long-term PPI or vonoprazan users.
Scientific Title:Acronym
The assessment of gastric histology in lon-term PPI users.
Region
| Japan |
Condition
Condition
GERD patients with long-term PPI or vonoprazan using
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The assessment of gastric histology in long-term PPI or vonoprazan users.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
gastric histology
Key secondary outcomes
long-term PPI or vonoprazan gastrin level, esophageal mucosal healing and symptom
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
GERD patients with long-term PPI or vonoprazan using
Key exclusion criteria
GERD patients with not continuous PPI or vonoprazan using( 1 year at least)
stomach surgery
sever liver failure, renal failure, heart failure.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kouichi |
| Middle name | |
| Last name | Sakurai |
Organization
Hattori clinic
Division name
Hattori Clinic
Zip code
860-0004
Address
2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL
+81-96-325-2300
sakuraiko@jcom.zaq.ne.jp
Public contact
Name of contact person
| 1st name | kouichi |
| Middle name | |
| Last name | Sakurai |
Organization
Hattori Clinic
Division name
Hattori Clinic
Zip code
860-0004
Address
2-12-35 Shin-machi, chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
TEL
+81-96-325-2300
Homepage URL
sakuraiko@jcom.zaq.ne.jp
Sponsor or person
Institute
Hattori Clinic
Institute
Department
Personal name
Funding Source
Organization
Hattori Clinic
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hirano Gastroenterology Clinic, Miyazaki, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hattori clinic
Address
Kumamoto, 2-12-35 Shin-machi, Chuo-ku, Kumamoto City, Kumamoto 860-0004, Japan
Tel
0963252300
sakuraiko@jcom.zaq.ne.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
| 2017 | Year | 12 | Month | 01 | 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
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The assessment of gastrin level and gastric histology(take biopsy both body and antrum) every year if GERD patients take continuous PPI or vonoprazan.
and take a biopsy of duodenum.
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032866
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
