UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041094 |
|---|---|
| Receipt number | R000046930 |
| Scientific Title | Epidemiology and clinical characteristics - based Rome III and IV criteria in Japanese FD patients: a multicenter prospective observational study |
| Date of disclosure of the study information | 2020/07/13 |
| Last modified on | 2020/07/13 18:22:46 |
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Basic information
Public title
Epidemiology and clinical characteristics - based Rome III and IV criteria in Japanese FD patients: a multicenter prospective observational study
Acronym
Epidemiology and clinical characteristics - based Rome III and IV criteria in Japanese FD patients
Scientific Title
Epidemiology and clinical characteristics - based Rome III and IV criteria in Japanese FD patients: a multicenter prospective observational study
Scientific Title:Acronym
Epidemiology and clinical characteristics - based Rome III and IV criteria in Japanese FD patients
Region
| Japan |
Condition
Condition
functional dyspepsia by Rome III,IV criteria
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the frequency by Rome criteria questionnaire on functional dyspepsia
Basic objectives2
Others
Basic objectives -Others
clinical characteristics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each percentage of functional dyspepsia typing (PDS, EPS, overlap) in Rome III, IV criteria
Key secondary outcomes
Characteristics of the patients
Comorbidity of irritable bowel syndrome
Comorbidity of gastroesophageal reflux disease
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 with functional dyspepsia who visited a hospital and related hospitals
Key exclusion criteria
Targets that may affect the answers in the questionnaire
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Miwa |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology,Department of Internal Medicine
Zip code
663-8501
Address
1-1,Mukogawa-cho,Nishinomiya,Hyogo 663-8501,Japan
TEL
+81-798-45-6662
miwahgi@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Tomita |
Organization
Hyogo College of Medicine
Division name
Division of Gastroenterology,Department of Internal Medicine
Zip code
663-8501
Address
1-1,Mukogawa-cho,Nishinomiya,Hyogo 663-8501,Japan
TEL
+81-798-45-6662
Homepage URL
tomita@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo College of Medicine
Address
1-1,Mukogawa-cho,Nishinomiya,Hyogo 663-8501,Japan
Tel
+81-798-45-6662
tomita@hyo-med.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
| 2020 | Year | 07 | Month | 13 | 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
| 2020 | Year | 05 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is multicenter study.
Management information
Registered date
| 2020 | Year | 07 | Month | 13 | Day |
Last modified on
| 2020 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046930
| Research Plan | |
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| 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 |
