Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation
NCT ID: NCT01051388
Last Updated: 2011-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
280 participants
INTERVENTIONAL
2008-08-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Group I
Low-dose PPI (Rabeprazole sodium 10 mg)
Low-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
Group II
High-dose PPI (Rabeprazole sodium 20 mg)
High-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
Group III
Non-PPI (Gefarnate)
Non-PPI (Gefarnate)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
Interventions
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Low-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
High-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
Non-PPI (Gefarnate)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
Eligibility Criteria
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Inclusion Criteria
* patients taking low-dose aspirin to prevent relapse of vascular diseases
* patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
* patients without active gastric and duodenal ulcers
* more than 20 years old
* outpatients
* patients written an informed consent
Exclusion Criteria
* patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
* patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
* patients who are treated with steroid hormones
* patients who are women of, pregnant and lactating and childbearing
* patients who are alcoholism
* patients who show the hypersensitivity for test drugs
* patients who are enrolled in another clinical study
* patients who are judged as unsuitable by investigator
20 Years
ALL
No
Sponsors
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Gastro-Intestinal Medical Care Research Center
UNKNOWN
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
OTHER
Responsible Party
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Kobe University, School of Medicine
Principal Investigators
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Takeshi Azuma, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Kobe University, School of Medicine
Locations
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Kobe University, School of Medicine
Kobe, Hyōgo, Japan
Countries
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Related Links
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Other Identifiers
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UMIN000002901
Identifier Type: OTHER
Identifier Source: secondary_id
TRIGID0801
Identifier Type: -
Identifier Source: org_study_id
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