Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin
NCT ID: NCT01069939
Last Updated: 2012-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2010-02-28
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Esomeprazole 20mg
Esomeprazole 20mg once daily oral
Esomeprazole
20mg, capsule, 72 weeks
Placebo
Placebo once daily oral
Placebo
Placebo, capsule, 72 weeks
Interventions
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Esomeprazole
20mg, capsule, 72 weeks
Placebo
Placebo, capsule, 72 weeks
Eligibility Criteria
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Inclusion Criteria
* Patients who have the history of gastric and/or duodenal ulcer.
* A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.
Exclusion Criteria
* History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.
20 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Kentaro Sugano, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Jichi Medical University
Locations
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Research Site
Yotsukaidou, Chiba, Japan
Research Site
Fukui-shi, Fukui, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Kitakyushu-Shi, Fukuoka, Japan
Research Site
Onga-Gun, Fukuoka, Japan
Research Site
Yukuhashi, Fukuoka, Japan
Research Site
Fukushima, Fukushima, Japan
Research Site
Kōriyama, Fukushima, Japan
Research Site
Nihommatsu, Fukushima, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Kure, Hiroshima, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Amagasaki, Hyōgo, Japan
Research Site
Itami, Hyōgo, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Nishinomiya, Hyōgo, Japan
Research Site
Higashi-ibaraki,, Ibaraki, Japan
Research Site
Komatsu, Ishikawa-ken, Japan
Research Site
Nomi, Ishikawa-ken, Japan
Research Site
Kawasaki-shi, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Uji, Kyoto, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Daitō, Osaka, Japan
Research Site
Kishiwada, Osaka, Japan
Research Site
Matsubara, Osaka, Japan
Research Site
Minato, Osaka, Japan
Research Site
Yao, Osaka, Japan
Research Site
Hanyū, Saitama, Japan
Research Site
Shizuoka, Shizuoka, Japan
Research Site
Shimotsuke, Tochigi, Japan
Research Site
Chūō, Tokyo, Japan
Research Site
Minato, Tokyo, Japan
Research Site
Shinagawa, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
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Shimonoseki, Yamaguchi, Japan
Research Site
Gangneung, Gangwon-do, South Korea
Research Site
Wŏnju, Gangwon-do, South Korea
Research Site
Seongnam-si, Gyeonggi-do, South Korea
Research Site
Busan, , South Korea
Research Site
Seoul, , South Korea
Research Site
Niao-Song-Shiang, Kaohsiung, Taiwan
Research Site
Kweishan Shiang, Taoyuan Hsien, Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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References
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Sugano K, Choi MG, Lin JT, Goto S, Okada Y, Kinoshita Y, Miwa H, Chiang CE, Chiba T, Hori M, Fukushima Y, Kim HS, Chang CY, Date M; LAVENDER Study Group. Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study. Gut. 2014 Jul;63(7):1061-8. doi: 10.1136/gutjnl-2013-304722. Epub 2013 Dec 10.
Other Identifiers
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D961PC00001
Identifier Type: -
Identifier Source: org_study_id