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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024049
Receipt No. R000027535
Scientific Title The comparison on effectiveness between mopride and acotiamide in the functional dyspepsia patients
Date of disclosure of the study information 2016/09/15
Last modified on 2019/01/10

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Basic information
Public title The comparison on effectiveness between mopride and acotiamide in the functional dyspepsia patients
Acronym Prokinetics for functional dyspepsia
Scientific Title The comparison on effectiveness between mopride and acotiamide in the functional dyspepsia patients
Scientific Title:Acronym Prokinetics for functional dyspepsia
Region
Japan

Condition
Condition functional dyspepsia
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the effectiveness between mosapride and acotiamide.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes GSRS score and SF-36 score after taking prokinetics for 14 weeks
Key secondary outcomes clinical characteristics in the patients with effectiveness

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Patients taking mosapride 5mg three times per day for 14 days
Interventions/Control_2 Patients taking acotiamide 100mg three times per day for 14 days
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 diagnosed as functional dyspepsia using ROMA4 criteria
Key exclusion criteria Patients already taking prokinetics
patients with changed treatment during the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiotani Akiko
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577 Matsusima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Email shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiotani Akiko
Organization Kawasaki Medical School
Division name Gastroenterology
Zip code
Address 577 Matsusima, Kurashiki city, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email shiotani@med.kawasaki-m.ac.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 09 Month 15 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 Completed
Date of protocol fixation
2016 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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 09 Month 14 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027535

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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