Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
NCT ID: NCT00770913
Last Updated: 2012-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
337 participants
INTERVENTIONAL
2008-10-31
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
TREATMENT
DOUBLE
Study Groups
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1
E3810
20 mg taken orally, once a day for 8 weeks.
2
E3810
10 mg, taken orally, twice a day for 8 weeks.
3
E3810
20 mg taken orally, twice a day for 8 weeks.
Interventions
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E3810
20 mg taken orally, once a day for 8 weeks.
E3810
10 mg, taken orally, twice a day for 8 weeks.
E3810
20 mg taken orally, twice a day for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Proton Pump Inhibitor standard dose-resistant reflux esophagitis.
* Patients who are 20 years and older when informed consent is obtained.
Exclusion Criteria
* Patients with malignancy.
* Patients who are taking another trial drug or the interval between the end of treatment and screening is less than 12 weeks.
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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Tomoki Kubota
Role: STUDY_DIRECTOR
New Product Development Dept., Clinical Research Center
Locations
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Nagakute, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Akita, Akita, Japan
Abiko, Chiba, Japan
Kashiwa, Chiba, Japan
Yachiyo, Chiba, Japan
Chikushino-shi, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Omuta, Fukuoka, Japan
Tagawa, Fukuoka, Japan
Kōriyama, Fukushima, Japan
Gifu, Gifu, Japan
Hashima, Gifu, Japan
Maebashi, Gunma, Japan
Hiroshima, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Itami, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Hitachi, Ibaraki, Japan
Takamatsu, Kagawa-ken, Japan
Kagoshima, Kagoshima-ken, Japan
Kirishima, Kagoshima-ken, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Kumamoto, Kumamoto, Japan
Kyoto, Kyoto, Japan
Ishinomaki, Miyagi, Japan
Nagasaki, Nagasaki, Japan
Yamatokōriyama, Nara, Japan
Beppu, Oita Prefecture, Japan
Ōita, Oita Prefecture, Japan
Okayama, Okayama-ken, Japan
Hirakata, Osaka, Japan
Osaka, Osaka, Japan
Karatsu, Saga-ken, Japan
Saga, Saga-ken, Japan
Kusatsu, Shiga, Japan
Izumo, Shimane, Japan
Matsue, Shimane, Japan
Fujieda, Shizuoka, Japan
Hamamatsu, Shizuoka, Japan
Shimada, Shizuoka, Japan
Shizuoka, Shizuoka, Japan
Ohtawara, Tochigi, Japan
Bunkyo, Tokyo, Japan
Setagaya City, Tokyo, Japan
Shinagawa, Tokyo, Japan
Shinjuku, Tokyo, Japan
tabashi City, Tokyo, Japan
Yamagata, Yamagata, Japan
Hōfu, Yamaguchi, Japan
Shimonoseki, Yamaguchi, Japan
Countries
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Other Identifiers
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E3810-J081-304
Identifier Type: -
Identifier Source: org_study_id
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