UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024049 |
|---|---|
| Receipt number | 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 11:48:15 |
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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
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
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027535
| Research Plan | |
|---|---|
| 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 |
