UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002305 |
|---|---|
| Receipt number | R000002662 |
| Scientific Title | Efficacy of rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study. |
| Date of disclosure of the study information | 2009/08/06 |
| Last modified on | 2016/03/09 16:37:26 |
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Basic information
Public title
Efficacy of rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study.
Acronym
Efficacy of rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study.
Scientific Title
Efficacy of rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study.
Scientific Title:Acronym
Efficacy of rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study.
Region
| Japan |
Condition
Condition
Functional Dyspepsia
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are several reasons for functional dyspepsia . We want to research the efficacy of radical scavengers rebamipide for Functional Dyspepsia : Randomized, Double-Masked Comparative Study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Self-questionnaire for epigastric bloating etc.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Oral administration of rebamipide 100mg three times daily for 2 weeks.
Interventions/Control_2
Oral administration of placebo three times daily 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a.Obtaining informed consent
b.Patient of 20 years or more
c.Patient during reflux esophagitis and gastritis during PPI mentenance therapy with dyspepsia.
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2800
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2009 | Year | 08 | Month | 06 | 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
| 2009 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002662
