UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030407 |
|---|---|
| Receipt number | R000034724 |
| Scientific Title | Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD |
| Date of disclosure of the study information | 2019/01/01 |
| Last modified on | 2020/05/18 13:55:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Acronym
Effect of acid suppressor in serum level of gastrin
Scientific Title
Effect of acid suppressor in serum level of gastrin in Japanese patients with gastric ulcer after ESD
Scientific Title:Acronym
Effect of acid suppressor in serum level of gastrin
Region
| Japan |
Condition
Condition
gastric cancer post ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the difference in serum gastrin level after using acid suppressors
Basic objectives2
Others
Basic objectives -Others
To clarify the clinical features of patients who revealed the increased gastrin level after using PPI/P-Cab.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the difference in serum gastrin level after using acid suppressors
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) Patient who received endoscopic submucosal dissection of early gastric cancer.
2) Patients whose sera were collected before and after using acid suppressors.
3) Patients with written informed consent.
4) Over 20 years.
Key exclusion criteria
1) Patients with allergic reaction for PPI/P-Cab.
2) Under 20 years old.
3) Patients with previous gasterectomy.
4) Patients with insufficient treatment by ESD.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Ito |
Organization
Hiroshima University Hospital
Division name
Gastroenterology an Metabolism
Zip code
7348551
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
+81-82-257-5191
maito@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Ito |
Organization
Hiroshima University Hospital
Division name
Gastroenterology an Metabolism
Zip code
7348551
Address
1-2-3 Kasumi Minami-ku Hiroshima
TEL
+81-82-257-5191
Homepage URL
maito@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for integrated medical research Hiroshima University Hospital
Address
1-2-3 Kasumi Minanmi-ku Hirosima
Tel
082-257-1752
protocol@cimr.hiroshima-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
| 2019 | Year | 01 | 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
150
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
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 12 | Month | 15 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034724
