UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014246 |
|---|---|
| Receipt number | R000016595 |
| Scientific Title | Retrospective observational study about the effect of gastric acid suppressive drug on gastric mucosa |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2017/05/22 11:36:17 |
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Basic information
Public title
Retrospective observational study about the effect of gastric acid suppressive drug on gastric mucosa
Acronym
Effect of gastric acid suppressive drug on gastric mucosa
Scientific Title
Retrospective observational study about the effect of gastric acid suppressive drug on gastric mucosa
Scientific Title:Acronym
Effect of gastric acid suppressive drug on gastric mucosa
Region
| Japan |
Condition
Condition
gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of gastric acid suppressive drug on gastric mucosa.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Histological change of gastric mucosa in the antrum and corpus.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
966 patients who performed upper GI endoscopy with gastric biopsy in order to investigate gastritis and H. pylori infection between Jan 1, 2010 and March 31, 2013 in Kawasaki Medical School.
Key exclusion criteria
None
Target sample size
966
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoari Kamada |
Organization
Kawasaki Medical School
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL
086-462-1111
tkamada@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoari Kamada |
Organization
Kawasaki Medical School
Division name
Department of Internal Medicine, Division of Gastroenterology
Zip code
Address
577 Matsushima, Kurashiki, Okayama, 701-0192, Japan,
TEL
086-462-1111
Homepage URL
tkamada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc
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
| 2014 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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 | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2014 | Year | 06 | Month | 12 | Day |
Last modified on
| 2017 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016595
