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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041094
Receipt No. 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

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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
Email 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
Email tomita@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046930

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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