- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321567
Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
July 21, 2023 updated by: Eisai Co., Ltd.
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
2157
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mie, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Oita, Japan
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Okayama, Japan
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Osaka, Japan
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Saga, Japan
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Saitama, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamanashi, Japan
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Aichi
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Aisai, Aichi, Japan
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Anjo, Aichi, Japan
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Gamagori, Aichi, Japan
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Ichinomiya, Aichi, Japan
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Inuyama, Aichi, Japan
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Kariya, Aichi, Japan
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Kasugai, Aichi, Japan
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Nagoya, Aichi, Japan
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Okazaki, Aichi, Japan
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Owariasahi, Aichi, Japan
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Tokai, Aichi, Japan
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Tokoname, Aichi, Japan
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Toyota, Aichi, Japan
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Tsushima, Aichi, Japan
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Akita
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Daisen, Akita, Japan
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Yokote, Akita, Japan
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Yurihonjo, Akita, Japan
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Aomori
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Goshogawara, Aomori, Japan
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Hachinohe, Aomori, Japan
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Hirosaki, Aomori, Japan
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Kitatsugaru, Aomori, Japan
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Mutsu, Aomori, Japan
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Sannohe, Aomori, Japan
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Towada, Aomori, Japan
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Chiba
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Asahi, Chiba, Japan
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Choshi, Chiba, Japan
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Funabashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Kashiwa, Chiba, Japan
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Katori, Chiba, Japan
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Matsudo, Chiba, Japan
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Mobara, Chiba, Japan
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Narashino, Chiba, Japan
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Noda, Chiba, Japan
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Ehime
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Imabari, Ehime, Japan
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Kitauwa, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Ozu, Ehime, Japan
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Saijo, Ehime, Japan
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Uwajima, Ehime, Japan
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Fukui
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Mikatakaminaka, Fukui, Japan
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Ono, Fukui, Japan
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Sabae, Fukui, Japan
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Sakai, Fukui, Japan
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Fukuoka
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Asakura, Fukuoka, Japan
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Buzen, Fukuoka, Japan
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Chikujo, Fukuoka, Japan
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Chikushi, Fukuoka, Japan
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Chikushino, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kasuya, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Miyama, Fukuoka, Japan
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Munakata, Fukuoka, Japan
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Nogata, Fukuoka, Japan
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Okawa, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Tagawa, Fukuoka, Japan
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Yame, Fukuoka, Japan
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Fukushima
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Iwaki, Fukushima, Japan
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Koriyama, Fukushima, Japan
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Shirakawa, Fukushima, Japan
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Soma, Fukushima, Japan
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Yama, Fukushima, Japan
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Gifu
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Hashima, Gifu, Japan
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Kakamigahara, Gifu, Japan
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Minokamo, Gifu, Japan
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Mizunami, Gifu, Japan
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Ogaki, Gifu, Japan
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Seki, Gifu, Japan
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Tajimi, Gifu, Japan
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Takayama, Gifu, Japan
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Gumma
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Agatsuma, Gumma, Japan
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Kiryu, Gumma, Japan
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Maebashi, Gumma, Japan
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Midori, Gumma, Japan
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Ota, Gumma, Japan
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Takasaki, Gumma, Japan
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Hiroshima
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Aki, Hiroshima, Japan
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Fukuyama, Hiroshima, Japan
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Higashihiroshima, Hiroshima, Japan
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Kure, Hiroshima, Japan
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Mihara, Hiroshima, Japan
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Miyoshi, Hiroshima, Japan
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Onomichi, Hiroshima, Japan
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Takehara, Hiroshima, Japan
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Hokkaido
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Abashiri, Hokkaido, Japan
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Abuta, Hokkaido, Japan
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Asahikawa, Hokkaido, Japan
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Date, Hokkaido, Japan
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Ebetsu, Hokkaido, Japan
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Eniwa, Hokkaido, Japan
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Fukagawa, Hokkaido, Japan
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Furano, Hokkaido, Japan
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Hakodate, Hokkaido, Japan
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Hokuto, Hokkaido, Japan
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Ishikari, Hokkaido, Japan
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Kamiiso, Hokkaido, Japan
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Kasai, Hokkaido, Japan
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Kato, Hokkaido, Japan
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Kayabe, Hokkaido, Japan
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Kitami, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Muroran, Hokkaido, Japan
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Nakagawa, Hokkaido, Japan
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Obihiro, Hokkaido, Japan
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Otaru, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Shibetsu, Hokkaido, Japan
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Suttsu, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Yoichi, Hokkaido, Japan
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Hyogo
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Aioi, Hyogo, Japan
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Akashi, Hyogo, Japan
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Ako, Hyogo, Japan
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Amagasaki, Hyogo, Japan
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Ashiya, Hyogo, Japan
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Awaji, Hyogo, Japan
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Himeji, Hyogo, Japan
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Itami, Hyogo, Japan
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Kakogawa, Hyogo, Japan
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Kobe, Hyogo, Japan
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Miki, Hyogo, Japan
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Nishinomiya, Hyogo, Japan
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Ono, Hyogo, Japan
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Sanda, Hyogo, Japan
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Sasayama, Hyogo, Japan
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Sumoto, Hyogo, Japan
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Takarazuka, Hyogo, Japan
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Tamba, Hyogo, Japan
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Ibaraki
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Bando, Ibaraki, Japan
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Hitachi, Ibaraki, Japan
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Hitachiota, Ibaraki, Japan
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Hokota, Ibaraki, Japan
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Ishioka, Ibaraki, Japan
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Itako, Ibaraki, Japan
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Joso, Ibaraki, Japan
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Kitaibaraki, Ibaraki, Japan
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Koga, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Moriya, Ibaraki, Japan
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Naka, Ibaraki, Japan
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Ryugasaki, Ibaraki, Japan
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Shimotsuma, Ibaraki, Japan
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Tsukuba, Ibaraki, Japan
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Ushiku, Ibaraki, Japan
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Ishikawa
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Hakui, Ishikawa, Japan
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Hakusan, Ishikawa, Japan
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Kahoku, Ishikawa, Japan
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Kanazawa, Ishikawa, Japan
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Nomi, Ishikawa, Japan
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Iwate
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Hanamaki, Iwate, Japan
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Ichinoseki, Iwate, Japan
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Morioka, Iwate, Japan
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Oshu, Iwate, Japan
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Tono, Iwate, Japan
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Kagawa
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Kanonji, Kagawa, Japan
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Marugame, Kagawa, Japan
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Mitoyo, Kagawa, Japan
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Takamatsu, Kagawa, Japan
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Kagoshima
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Aira, Kagoshima, Japan
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Ichikikushikino, Kagoshima, Japan
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Isa, Kagoshima, Japan
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Izumi, Kagoshima, Japan
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Kanoya, Kagoshima, Japan
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Kirishima, Kagoshima, Japan
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Kumage, Kagoshima, Japan
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Satsumasendai, Kagoshima, Japan
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Kanagawa
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Ashigarashimo, Kanagawa, Japan
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Atsugi, Kanagawa, Japan
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Chigasaki, Kanagawa, Japan
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Fujisawa, Kanagawa, Japan
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Hadano, Kanagawa, Japan
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Hiratsuka, Kanagawa, Japan
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Isehara, Kanagawa, Japan
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Kamakura, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Minamiashigara, Kanagawa, Japan
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Naka, Kanagawa, Japan
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Odawara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Zama, Kanagawa, Japan
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Kumamoto
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Aso, Kumamoto, Japan
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Hitoyoshi, Kumamoto, Japan
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Kamimashiki, Kumamoto, Japan
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Koshi, Kumamoto, Japan
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Kuma, Kumamoto, Japan
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Yatsushiro, Kumamoto, Japan
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Kyoto
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Fukuchiyama, Kyoto, Japan
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Kameoka, Kyoto, Japan
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Kyotango, Kyoto, Japan
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Maizuru, Kyoto, Japan
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Muko, Kyoto, Japan
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Nantan, Kyoto, Japan
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Yosa, Kyoto, Japan
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Mie
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Iga, Mie, Japan
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Ise, Mie, Japan
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Kameyama, Mie, Japan
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Kitamuro, Mie, Japan
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Kuwana, Mie, Japan
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Matsusaka, Mie, Japan
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Suzuka, Mie, Japan
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Tsu, Mie, Japan
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Yokkaichi, Mie, Japan
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Miyagi
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Osaki, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiroishi, Miyagi, Japan
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Toda, Miyagi, Japan
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Tome, Miyagi, Japan
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Miyazaki
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Ebino, Miyazaki, Japan
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Hyuga, Miyazaki, Japan
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Koyu, Miyazaki, Japan
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Kushima, Miyazaki, Japan
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Miyakonojo, Miyazaki, Japan
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Nobeoka, Miyazaki, Japan
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Nagano
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Ina, Nagano, Japan
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Kamiina, Nagano, Japan
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Kiso, Nagano, Japan
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Komagane, Nagano, Japan
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Matsumoto, Nagano, Japan
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Nakano, Nagano, Japan
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Saku, Nagano, Japan
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Ueda, Nagano, Japan
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Nagasaki
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Isahaya, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Unzen, Nagasaki, Japan
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Nara
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Gojo, Nara, Japan
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Ikoma, Nara, Japan
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Kashihara, Nara, Japan
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Kitakatsuragi, Nara, Japan
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Sakurai, Nara, Japan
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Tenri, Nara, Japan
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Uda, Nara, Japan
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Yamatokoriyama, Nara, Japan
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Yamatotakada, Nara, Japan
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Niigata
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Joetsu, Niigata, Japan
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Kashiwazaki, Niigata, Japan
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Minamiuonuma, Niigata, Japan
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Mitsuke, Niigata, Japan
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Nagaoka, Niigata, Japan
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Sado, Niigata, Japan
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Shibata, Niigata, Japan
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Tokamachi, Niigata, Japan
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Oita
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Kunisaki, Oita, Japan
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Nakatsu, Oita, Japan
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Taketa, Oita, Japan
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Usa, Oita, Japan
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Yufu, Oita, Japan
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Okayama
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Akaiwa, Okayama, Japan
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Asakuchi, Okayama, Japan
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Bizen, Okayama, Japan
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Kurashiki, Okayama, Japan
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Niimi, Okayama, Japan
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Tsukubo, Okayama, Japan
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Tsuyama, Okayama, Japan
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Okinawa
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Itoman, Okinawa, Japan
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Nago, Okinawa, Japan
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Nakagami, Okinawa, Japan
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Tomigusuku, Okinawa, Japan
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Urasoe, Okinawa, Japan
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Osaka
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Daito, Osaka, Japan
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Fujiidera, Osaka, Japan
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Higashiosaka, Osaka, Japan
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Hirakata, Osaka, Japan
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Ibaraki, Osaka, Japan
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Izumi, Osaka, Japan
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Izumiotsu, Osaka, Japan
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Izumisano, Osaka, Japan
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Kadoma, Osaka, Japan
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Katano, Osaka, Japan
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Kishiwada, Osaka, Japan
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Matsubara, Osaka, Japan
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Minamikawachi, Osaka, Japan
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Mino, Osaka, Japan
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Moriguchi, Osaka, Japan
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Neyagawa, Osaka, Japan
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Osakasayama, Osaka, Japan
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Sakai, Osaka, Japan
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Sennan, Osaka, Japan
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Settsu, Osaka, Japan
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Suita, Osaka, Japan
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Takaishi, Osaka, Japan
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Takatsuki, Osaka, Japan
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Tondabayashi, Osaka, Japan
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Toyonaka, Osaka, Japan
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Yao, Osaka, Japan
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Saga
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Imari, Saga, Japan
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Kanzaki, Saga, Japan
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Ogi, Saga, Japan
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Takeo, Saga, Japan
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Taku, Saga, Japan
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Tosu, Saga, Japan
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Saitama
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Ageo, Saitama, Japan
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Chichibu, Saitama, Japan
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Fujimi, Saitama, Japan
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Fukaya, Saitama, Japan
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Hanno, Saitama, Japan
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Hidaka, Saitama, Japan
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Kasukabe, Saitama, Japan
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Kawagoe, Saitama, Japan
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Kawaguchi, Saitama, Japan
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Kazo, Saitama, Japan
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Kitaadachi, Saitama, Japan
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Koshigaya, Saitama, Japan
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Kuki, Saitama, Japan
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Sayama, Saitama, Japan
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Toda, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Warabi, Saitama, Japan
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Shiga
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Koka, Shiga, Japan
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Kusatsu, Shiga, Japan
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Moriyama, Shiga, Japan
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Nagahama, Shiga, Japan
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Otsu, Shiga, Japan
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Ritto, Shiga, Japan
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Shimane
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Izumo, Shimane, Japan
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Matsue, Shimane, Japan
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Yasugi, Shimane, Japan
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Shizuoka
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Fuji, Shizuoka, Japan
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Fujieda, Shizuoka, Japan
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Fujinomiya, Shizuoka, Japan
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Fukuroi, Shizuoka, Japan
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Hamamatsu, Shizuoka, Japan
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Ito, Shizuoka, Japan
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Iwata, Shizuoka, Japan
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Kikugawa, Shizuoka, Japan
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Mishima, Shizuoka, Japan
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Numazu, Shizuoka, Japan
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Shimada, Shizuoka, Japan
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Shimoda, Shizuoka, Japan
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Susono, Shizuoka, Japan
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Yaizu, Shizuoka, Japan
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Tochigi
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Moka, Tochigi, Japan
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Nikko, Tochigi, Japan
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Sano, Tochigi, Japan
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Shimotsuga, Tochigi, Japan
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Utsunomiya, Tochigi, Japan
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Tokushima
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Anan, Tokushima, Japan
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Awa, Tokushima, Japan
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Itano, Tokushima, Japan
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Myozai, Tokushima, Japan
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Naruto, Tokushima, Japan
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Tokyo
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Adachi, Tokyo, Japan
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Akiruno, Tokyo, Japan
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Akishima, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Chiyoda, Tokyo, Japan
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Chuo, Tokyo, Japan
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Edogawa, Tokyo, Japan
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Fuchu, Tokyo, Japan
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Hachioji, Tokyo, Japan
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Higashimurayama, Tokyo, Japan
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Higashiyamato, Tokyo, Japan
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Hino, Tokyo, Japan
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Inagi, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Katsushika, Tokyo, Japan
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Kita, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Koganei, Tokyo, Japan
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Koto, Tokyo, Japan
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Machida, Tokyo, Japan
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Meguro, Tokyo, Japan
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Minato, Tokyo, Japan
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Mitaka, Tokyo, Japan
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Nakano, Tokyo, Japan
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Nerima, Tokyo, Japan
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Nishitokyo, Tokyo, Japan
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Ome, Tokyo, Japan
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Ota, Tokyo, Japan
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Setagaya, Tokyo, Japan
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Shibuya, Tokyo, Japan
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Shinagawa, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Suginami, Tokyo, Japan
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Sumida, Tokyo, Japan
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Tachikawa, Tokyo, Japan
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Toshima, Tokyo, Japan
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Tottori
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Kurayoshi, Tottori, Japan
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Sakaiminato, Tottori, Japan
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Toyama
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Imizu, Toyama, Japan
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Kurobe, Toyama, Japan
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Nakaniikawa, Toyama, Japan
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Namerikawa, Toyama, Japan
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Nanto, Toyama, Japan
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Takaoka, Toyama, Japan
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Tonami, Toyama, Japan
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Wakayama
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Hidaka, Wakayama, Japan
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Higashimuro, Wakayama, Japan
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Iwade, Wakayama, Japan
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Kainan, Wakayama, Japan
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Nishimuro, Wakayama, Japan
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Tanabe, Wakayama, Japan
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Yamagata
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Higashiokitama, Yamagata, Japan
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Kaminoyama, Yamagata, Japan
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Sakata, Yamagata, Japan
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Yamaguchi
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Hagi, Yamaguchi, Japan
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Hikari, Yamaguchi, Japan
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Iwakuni, Yamaguchi, Japan
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SanyoOnoda, Yamaguchi, Japan
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Shimonoseki, Yamaguchi, Japan
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Ube, Yamaguchi, Japan
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Yanai, Yamaguchi, Japan
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Yamanashi
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Chuo, Yamanashi, Japan
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Fuefuki, Yamanashi, Japan
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Kofu, Yamanashi, Japan
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Koshu, Yamanashi, Japan
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Minami-Alps, Yamanashi, Japan
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Minamikoma, Yamanashi, Japan
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Tsuru, Yamanashi, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Hospitals and Clinics in Japan
Description
Inclusion criteria;
-Proton pump inhibitor-resistant reflux esophagitis. (Patients who have mucosal breaks (erosions, ulcers) on endoscopy)
Exclusion criteria;
- Patients with a history of hypersensitivity to any ingredients of PARIET.
- Patients on atazanavir sulfate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Rabeprazole Sodium
|
Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective.
However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with improvement based on health related Quality of Life (QOL) questionnaire
Time Frame: Check at predose, 4, 8, 16 and 32 weeks
|
Check at predose, 4, 8, 16 and 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects with improvement in symptoms of GERD
Time Frame: Check at predose, 4, 8, 16 and 32 weeks
|
Check at predose, 4, 8, 16 and 32 weeks
|
Endoscopic healing rate
Time Frame: 8 weeks
|
8 weeks
|
Adverse events
Time Frame: Every 4-8 weeks
|
Every 4-8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yoshinori Furuhata, Drug Fostering and Evolution Coordination Department, Corporate Regulatory Compliance, Safety and Quality Assurance Headquarters, Eisai Co., Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
March 18, 2011
First Submitted That Met QC Criteria
March 22, 2011
First Posted (Estimated)
March 23, 2011
Study Record Updates
Last Update Posted (Estimated)
July 24, 2023
Last Update Submitted That Met QC Criteria
July 21, 2023
Last Verified
May 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Esophagitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Rabeprazole
Other Study ID Numbers
- PRT11T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Refractory Reflux Esophagitis
-
Eisai Co., Ltd.Completed
-
Xijing Hospital of Digestive DiseasesShaanxi Provincial People's Hospital; Baoji Central Hospital; Hanzhong Central... and other collaboratorsUnknownRefractory Reflux EsophagitisChina
-
AstraZenecaCompletedRefractory Reflux EsophagitisJapan
-
Universitair Ziekenhuis BrusselUnknownAcid Reflux Esophagitis | Non-acid Reflux EsophagitisBelgium
-
Ruihua ShiUnknownRefractory Gastroesophageal Reflux DiseaseChina
-
AstraZenecaCompletedGastroesophageal Reflux Disease | Erosive Esophagitis | Reflux EsophagitisUnited States
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
Trio Medicines Ltd.Ferring PharmaceuticalsCompletedReflux OesophagitisUnited Kingdom
-
Seoul National University Bundang HospitalCompletedNon-erosive Reflux Disease (NERD) | Reflux Esophagitis (RE) | Functional Heartburn (FH)Korea, Republic of
-
AstraZenecaCompletedRepeatedly Recurring Esophagitis | Relapsing Reflux EsophagitisJapan
Clinical Trials on rabeprazole sodium
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Johnson & Johnson Pharmaceutical Research & Development...Completed
-
Eisai Co., Ltd.Completed
-
Janssen Research & Development, LLCEisai Inc.CompletedGastroesophageal Reflux Disease (GERD)United States, Poland, United Kingdom, Belgium, Brazil
-
Eisai Inc.CompletedSymptomatic Gastroesophageal Reflux Disease (sGERD)United States
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Yungjin Pharm. Co., Ltd.Seoul National University HospitalCompletedGastroesophageal Reflux DiseaseKorea, Republic of
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Johnson & Johnson Pharmaceutical Research & Development...Eisai Inc.CompletedGastroesophageal RefluxUnited States, Belgium, Israel, Poland, Australia, Netherlands, South Africa, Hungary, Bulgaria, Denmark
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Zeria PharmaceuticalCompleted
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Zeria PharmaceuticalCompleted
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Sihuan Pharmaceutical Holdings Group Ltd.Completed