UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013845 |
|---|---|
| Receipt number | R000014844 |
| Scientific Title | Protective efficacy of rebamipide for the aspirin induced gastric/small intestinal injury;the clinical trials for volunteers |
| Date of disclosure of the study information | 2014/04/30 |
| Last modified on | 2014/04/30 15:17:21 |
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Basic information
Public title
Protective efficacy of rebamipide for the aspirin induced gastric/small intestinal injury;the clinical trials for volunteers
Acronym
Protective efficacy of rebamipide for the aspirin induced gastric/small intestinal injury
Scientific Title
Protective efficacy of rebamipide for the aspirin induced gastric/small intestinal injury;the clinical trials for volunteers
Scientific Title:Acronym
Protective efficacy of rebamipide for the aspirin induced gastric/small intestinal injury
Region
| Japan |
Condition
Condition
NSAIDs induced small intestinal injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examined the protective efficacy for the low-dose aspirin-induced gastric and small intestinal injury for humans using rebamipide of the defense factor augmentation drug.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the small intestinal injuries induced by NSAIDs
Key secondary outcomes
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
LDA(100mg) and Omeprazole 10mg/day for 2 weeks by oral administration
Interventions/Control_2
LDA(100mg) and Rebamipide 300mg/day for 2 weeks by oral administration
Interventions/Control_3
LDA(100mg) and Rebamipide 900mg/day for 2 weeks by oral administration
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults who are 20years or older,and less than 80years of age at the time of obtaining informed consent.
Key exclusion criteria
not accepted the above informed concent
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Higuchi |
Organization
Osaka Medical College
Division name
Second Dep of Internal Medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki-city, Osaka. JAPAN
TEL
072-683-1221
in2038@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Umegaki |
Organization
Osaka Medical College
Division name
Second Dep of Internal Medicine
Zip code
Address
2-7, Daigakumachi, Takatsuki-city, Osaka. JAPAN
TEL
072-683-1221
Homepage URL
in2038@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
| 2014 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2014 | Year | 04 | Month | 30 | Day |
Last modified on
| 2014 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014844
