UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007639 |
|---|---|
| Receipt number | R000009012 |
| Scientific Title | Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study) |
| Date of disclosure of the study information | 2012/04/02 |
| Last modified on | 2014/04/15 11:26:06 |
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Basic information
Public title
Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study)
Acronym
Quality study
Scientific Title
Adequate therapy against low-dose aspirin-induced ulcer: comparison of two acid-inhibitory drugs, rabeprazole and famotidine (Quality study)
Scientific Title:Acronym
Quality study
Region
| Japan |
Condition
Condition
gastric ulcer during usage of low dose aspirin (80-100 mg/day)
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate which is more effective drug for improvement of low-dose aspirin-induced ulcer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of endscopic finding 4 weeks and 8 weeks after initiating rabeprazole or famotidine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rabeprazole sodium
Interventions/Control_2
famotidine
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
1. Patients of 20 years or older
2. Patients taking low-dose aspirin more than 4 weeks
3. Patients who will take low-dose aspirin at least 8 weeks
4. Patients with written informed consent
Key exclusion criteria
1. Patients with allergy for rabeprazole and famotidine
2. Patients who have taken endoscopic banding
3. Patients who have taken digestive surgical procedure
4. Patients under treatment of atazanavir sulfate
5. Patients who have taken proton pomp inhibiter within 2 weeks before endoscopy
6. Patients who have taken NSAIDS or steroid
7. Patients who have malignant neoplasm or serious disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Watanabe |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
1-4-3 Asahimachi, Abeno-ku Osaka City, Osaka 545-8585, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
watanabet@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate School of Medicine
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
| 2012 | Year | 04 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
| 2012 | Year | 04 | Month | 02 | Day |
Last modified on
| 2014 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009012
| 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 |
