Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID
NCT ID: NCT00542789
Last Updated: 2010-05-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
343 participants
INTERVENTIONAL
2007-08-31
2009-02-28
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
Placebo
Placebo
once daily oral
2
Esomeprazole 20 mg
Esomeprazole
20mg once daily oral
Interventions
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Esomeprazole
20mg once daily oral
Placebo
once daily oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Exclusion Criteria
* History of esophageal, gastric or duodenal surgery
* Having severe liver disease or chronic renal disease
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Naotsugu Oyama
Role: STUDY_DIRECTOR
AstraZeneca Japan
Locations
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Research Site
Chiryū, Aichi-ken, Japan
Research Site
Seto, Aichi-ken, Japan
Research Site
Yotukaido, Chiba, Japan
Research Site
Miyaodai, Fukuoka, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, HYOGOi, Japan
Research Site
Itami, Hyōgo, Japan
Research Site
Koto, Hyōgo, Japan
Research Site
Nishinomiya, Hyōgo, Japan
Research Site
Hitachi, Ibaragi, Japan
Research Site
Morioka, Iwate, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Kōtari, Kyoto, Japan
Research Site
Kyoto, Kyoto, Japan
Research Site
Chiisagata, Nagano, Japan
Research Site
Matsumoto, Nagano, Japan
Research Site
Nagano, Nagano, Japan
Research Site
Sasebo, Nagasaki, Japan
Research Site
Beppu, Oita Prefecture, Japan
Research Site
Ōita, Oita Prefecture, Japan
Research Site
Ibara, Okayama-ken, Japan
Research Site
Hirakata, Osaka, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Suita, Osaka, Japan
Research Site
Takatsuki, Osaka, Japan
Research Site
Kawagoe, Saitama, Japan
Research Site
Saitama, Saitama, Japan
Research Site
Fukuroi, Shizuoka, Japan
Research Site
Hamamatsu, Shizuoka, Japan
Research Site
Izunokuni, Shizuoka, Japan
Research Site
Maikinohara, Shizuoka, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Yaizu, Shizuoka, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chiyoda City, Tokyo, Japan
Research Site
Koto, Tokyo, Japan
Research Site
Musashimurayama, Tokyo, Japan
Countries
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References
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Sugano K, Kinoshita Y, Miwa H, Takeuchi T; Esomeprazole NSAID Preventive Study Group. Randomised clinical trial: esomeprazole for the prevention of nonsteroidal anti-inflammatory drug-related peptic ulcers in Japanese patients. Aliment Pharmacol Ther. 2012 Jul;36(2):115-25. doi: 10.1111/j.1365-2036.2012.05133.x. Epub 2012 May 16.
Other Identifiers
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D961HC00001
Identifier Type: -
Identifier Source: org_study_id
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