A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
NCT ID: NCT01089543
Last Updated: 2013-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
338 participants
INTERVENTIONAL
2010-04-30
2011-08-31
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
TREATMENT
DOUBLE
Study Groups
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Rabeprazole 10 mg
Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 20 mg
Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole 40 mg
Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Placebo
Placebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Interventions
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Rabeprazole
Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole
Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
Rabeprazole
Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
Placebo
Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participants diagnosed with irritable bowel syndrome, inflammatory bowel disease and serious constipation.
20 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yoshiumi Okubo
Role: STUDY_DIRECTOR
Eisai Co., Ltd.
Locations
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Nagoya, Aichi-ken, Japan
Akita, Akita, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Gifu, Gifu, Japan
Maebashi, Gunma, Japan
Hiroshima, Hiroshima, Japan
Sapporo, Hokkaido, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Tsuchiura, Ibaraki, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Miyazaki, Miyazaki, Japan
Ōita, Oita Prefecture, Japan
Yufu, Oita Prefecture, Japan
Nakagami, Okinawa, Japan
Hirakata, Osaka, Japan
Moriguchi, Osaka, Japan
Osaka, Osaka, Japan
Suita, Osaka, Japan
Takatsuki, Osaka, Japan
Karatsu, Saga-ken, Japan
Saga, Saga-ken, Japan
Saitama, Saitama, Japan
Kusatsu, Shiga, Japan
Izumo, Shimane, Japan
Fujieda, Shizuoka, Japan
Hamamatsu, Shizuoka, Japan
Shizuoka, Shizuoka, Japan
Ōtawara, Tochigi, Japan
Shimotsuga, Tochigi, Japan
Bunkyo, Tokyo, Japan
Mitaka, Tokyo, Japan
Nakano City, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya City, Tokyo, Japan
Shibuya City, Tokyo, Japan
Shinagawa, Tokyo, Japan
Yamagata, Yamagata, Japan
Countries
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References
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Iwakiri R, Tominaga K, Furuta K, Inamori M, Furuta T, Masuyama H, Kanke K, Nagahara A, Haruma K, Kinoshita Y, Higuchi K, Takahashi S, Kusano M, Iwakiri K, Kato M, Hongo M, Hiraishi H, Watanabe S, Miwa H, Naito Y, Fujimoto K, Arakawa T. Randomised clinical trial: rabeprazole improves symptoms in patients with functional dyspepsia in Japan. Aliment Pharmacol Ther. 2013 Oct;38(7):729-40. doi: 10.1111/apt.12444. Epub 2013 Aug 20.
Other Identifiers
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E3810-J081-204
Identifier Type: -
Identifier Source: org_study_id
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