UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033648 |
|---|---|
| Receipt number | R000030684 |
| Scientific Title | Clinical factors related with symptoms in patients with GERD |
| Date of disclosure of the study information | 2018/08/10 |
| Last modified on | 2018/08/06 21:40:30 |
* 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
Clinical factors related with symptoms in patients with GERD
Acronym
GERD stmptoms and gastrin levels
Scientific Title
Clinical factors related with symptoms in patients with GERD
Scientific Title:Acronym
GERD stmptoms and gastrin levels
Region
| Japan |
Condition
Condition
reflux esophagitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical factors including gastrin levels related with GERD symptoms
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between serum gastrin levels and F scale total scores
Key secondary outcomes
Correlation between serum gastrin levels and F scale GERD score or motility scores
Other factors including serum pepsinogen levels and known GERD risk factors, such as H. pylori infections, atrophic scores, hiatus hernia etc.
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
Patients taking PPI
Key exclusion criteria
GI bleeding, nausea, malignant lesions
history of gastrectomy, IBS, Renal failure, severe hepatic, renal, cardica dseases, taking NSAIDs, LDA, other antitrombotics, malignant anemia
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Internal Medicine Division of Gastroenterology
Zip code
Address
577 matsushima Kurashiki city
TEL
0874721111
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Internal Medicine Division of Gastroenterology
Zip code
Address
577 matsushima Kurashiki city
TEL
0874721111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Astra Zeneca
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
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
| 2018 | Year | 08 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Just start entry
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030684
