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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025079
Receipt No. R000028846
Scientific Title Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-
Date of disclosure of the study information 2016/11/30
Last modified on 2018/09/10

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Basic information
Public title Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-
Acronym Kurashiki FD study
Scientific Title Current status of functional dyspepsia treatment in Kurashiki district -multicener collaborative research-
Scientific Title:Acronym Kurashiki FD study
Region
Japan

Condition
Condition Functional gastrointestinal disorders
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Effective of treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improve subjective symptoms
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with PPI takes 2 weeks
Interventions/Control_2 Treatment with acotiamide for 2 weeks
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Functional dyspepsia
Key exclusion criteria Patients who has organic, systemic, metabolism disease, and history of post abdominal surgery. Patients who are using aspirin or NSAIDs, and pregnant. Patients who refused conent.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabe Noriaki
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
Address 577 Matsushima, Kurashiki
TEL 086-462-1111
Email n_manabe@hkg.odn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manabe Noriaki
Organization Kawasaki Medical School
Division name Division of Endoscopy and Ultrasonography
Zip code
Address 577 Matsushima, Kurashiki
TEL 086-462-1111
Homepage URL
Email n_manabe@hkg.odn.ne.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
Address
Tel
Email

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
2016 Year 11 Month 30 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
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 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

Management information
Registered date
2016 Year 11 Month 30 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028846

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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