UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032593 |
|---|---|
| Receipt number | R000036675 |
| Scientific Title | The factors related with GI symptoms in patients with GERD |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/02/22 21:37:56 |
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Basic information
Public title
The factors related with GI symptoms in patients with GERD
Acronym
GI symptoms in GERD patients
Scientific Title
The factors related with GI symptoms in patients with GERD
Scientific Title:Acronym
GI symptoms in GERD patients
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate association between symptoms of patients with reflux esophagitis (RE) and their factors in a cross-sectional manner.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate the association between total score evaluated by F-scale and fasting blood gastrin level
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) People aged 20 or older who have provided written consent to participate in this study
2) RE patients under treatment with acid suppressants
Key exclusion criteria
1) Patients with warning signs such as vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia), or sudden weight loss
2) Patients with a confirmed or suspected malignant lesion
3) Patients with a history of gastrointestinal resection or vagotomy
4) Patients with irritable bowel syndrome
5) Hypergastrinemic patients with renal failure, ZE syndrome, etc
6) Patients complicated by serious hepatic, renal, cardiac, or other diseases
7) Patients on NSAIDs and low-dose aspirin
8) Patients with pernicious anemia
9) Other patients judged by their attending physicians to be inappropriate for this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Shiotani |
Organization
Kawasaki Medical School
Division name
Internal Medicine Division of Gastroenterology
Zip code
701-0192
Address
577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL
0864621111
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Shiotani |
Organization
Kawasaki Medical School
Division name
Internal Medicine Division of Gastroenterology
Zip code
701-0192
Address
577 Matushima Kurasiki city Okayama 701-0192 Japan
TEL
0864621111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matushima Kurasiki city Okayama 701-0192 Japan
Tel
0864621111
kmsrec@med.kawasaki-m.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
| 2018 | Year | 06 | Month | 01 | 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
311
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 | 05 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
non
Management information
Registered date
| 2018 | Year | 05 | Month | 14 | Day |
Last modified on
| 2021 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036675
| 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 |
