PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
NCT ID: NCT00576706
Last Updated: 2011-11-16
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
396 participants
INTERVENTIONAL
2007-12-31
2010-03-31
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
QUADRUPLE
Study Groups
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1
Rebamipide
Rebamipide 100㎎, 12 weeks
2
Misoprostol
Misoprostol 200㎍ 12 weeks
Interventions
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Rebamipide
Rebamipide 100㎎, 12 weeks
Misoprostol
Misoprostol 200㎍ 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males or females 19 years of age
3. Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.
Exclusion Criteria
2. Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol
19 Years
ALL
No
Sponsors
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Korea Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Korea Otsuka Pharmaceutical Co.,Ltd.
Principal Investigators
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Soo-Heon Park, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Catholic University Hospital
Locations
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Bucheon-si, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Jinju, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Suwon, , South Korea
Countries
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Other Identifiers
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037-KOA-0701i
Identifier Type: -
Identifier Source: org_study_id