UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013961 |
|---|---|
| Receipt number | R000016263 |
| Scientific Title | A multicenter randomized trial comparing rabeprazole and itopride with functional dyspepsia in Japan: the NAGOYA study |
| Date of disclosure of the study information | 2014/05/20 |
| Last modified on | 2014/05/14 22:02:45 |
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Basic information
Public title
A multicenter randomized trial comparing rabeprazole and itopride with functional dyspepsia in Japan: the NAGOYA study
Acronym
A multicenter randomized trial comparing rabeprazole and itopride with functional dyspepsia in Japan
Scientific Title
A multicenter randomized trial comparing rabeprazole and itopride with functional dyspepsia in Japan: the NAGOYA study
Scientific Title:Acronym
A multicenter randomized trial comparing rabeprazole and itopride with functional dyspepsia in Japan
Region
| Japan |
Condition
Condition
Functional dyspepsia
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the therapeutic effects of rabeprazole, one of the proton pump inhibitor, and itopride in a randomized open-label trial
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change Rates in dyspepsia scores (FD scores) between pretreatment (100%) and each time-point
Key secondary outcomes
sub-analysis in FD scores of epigastric pain syndrome (EPS) and postprandial distress syndrome (PDS) based on the Rome III criteria
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole group
Interventions/Control_2
itopride group
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
Functional dyspepsia patients, in whom organic disease underwent upper endoscopy had been excluded, who met the Rome III criteria
Key exclusion criteria
1) history of gastrectomy
2) organic brain disease or schizophrenia
3) alcoholism or other abuse disorder
4) serious hormonal imbalances
5) serious heart, liver, kidney or hematopoietic disease
6) history of hypersensitivity to either of the test agents
7) pregnant or lactating women
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Kamiya |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8211
kamitake@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Kamiya |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterology and Metabolism
Zip code
Address
Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Japan
TEL
052-853-8211
Homepage URL
kamitake@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Okuda Naika Clinic, Adachi Clinic,
Fuji Hospital
Name of secondary funder(s)
none
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
名古屋市立大学病院（愛知県）、富士病院（愛知県）、奥田内科クリニック（愛知県）、
あだちクリニック（愛知県）、
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 20 | 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
Rabeprazole showed a significant Change Rates in FD score within 1 week, maintained until after 4 weeks. Significant CR in the FD scores was seen after 4 week with itopride.
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
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2010 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 14 | Day |
Last modified on
| 2014 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016263
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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