- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00919477
Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg (CAMON)
21 januari 2013 uppdaterad av: AstraZeneca
To gather information on the safety of monotherapy of Casodex® tablets 80 mg, targeting prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration).
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
712
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Aichi, Japan
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Akita, 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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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Nagasaki, Japan
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Nara, Japan
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Okayama, Japan
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Osaka, Japan
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Saitama, Japan
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Shizuoka, 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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Aichi
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Houmei, Aichi, Japan
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Inuyama, 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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Toyohashi, Aichi, Japan
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Toyota, Aichi, Japan
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Akita
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Odate, Akita, Japan
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Aomori
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Hirosaki, Aomori, Japan
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Chiba
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Asahi, Chiba, Japan
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Funahashi, Chiba, Japan
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Ichihara, Chiba, Japan
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Ichikawa, Chiba, Japan
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Narashino, Chiba, Japan
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Sakura, Chiba, Japan
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Ehime
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Imabari, Ehime, Japan
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Matsuyama, Ehime, Japan
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Niihama, Ehime, Japan
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Uwajima, Ehime, Japan
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Fukuoka
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Chikushino, Fukuoka, Japan
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Iizuka, Fukuoka, Japan
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Kasuga, Fukuoka, Japan
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Kita Kyushu, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Yukuhashi, Fukuoka, Japan
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Fukushima
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Aizuwakamatsu, Fukushima, Japan
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Gifu
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Ibi, Gifu, Japan
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Kani, 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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Yamagata, Gifu, Japan
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Yourou, Gifu, Japan
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Gunma
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Isesaki, Gunma, Japan
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Kiryu, Gunma, Japan
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Numata, Gunma, Japan
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Ohta, Gunma, Japan
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Takasaki, Gunma, Japan
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Hokkaido
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Asahikawa, Hokkaido, Japan
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Eniwa, Hokkaido, Japan
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Kushiro, Hokkaido, Japan
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Sapporo, Hokkaido, Japan
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Sunagawa, Hokkaido, Japan
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Tomakomai, Hokkaido, Japan
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Hyogo
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Akashi, Hyogo, Japan
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Katou, Hyogo, Japan
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Kobe, Hyogo, Japan
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Takarazuka, Hyogo, Japan
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Ibaraki
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Hitachi, Ibaraki, Japan
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Mito, Ibaraki, Japan
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Sashima, Ibaraki, Japan
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Toride, Ibaraki, Japan
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Tsuchiura, Ibaraki, Japan
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Ishihawa
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Hakusan, Ishihawa, Japan
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Iwate
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Ichinoseki, Iwate, Japan
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Kamaishi, Iwate, Japan
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Miyako, Iwate, Japan
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Morioka, Iwate, Japan
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Shiwa, Iwate, Japan
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Kagawa
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Takamatsu, Kagawa, Japan
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Zentrsuji, Kagawa, Japan
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Kagoshima
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Minami Satsuma, Kagoshima, Japan
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Kanagawa
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Atsugi, Kanagawa, Japan
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Chigasaki, Kanagawa, Japan
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Ebina, Kanagawa, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yamato, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Kyoto
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Nantan, Kyoto, Japan
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Mie
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Inabe, Mie, Japan
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Tsu, Mie, Japan
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Miyagi
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Matsushima, Miyagi, Japan
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Natori, Miyagi, Japan
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Sendai, Miyagi, Japan
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Shiogama, Miyagi, Japan
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Tagajo, Miyagi, Japan
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Nagasaki
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Isahaya, Nagasaki, Japan
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Sasebo, Nagasaki, Japan
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Nara
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Ikoma, Nara, Japan
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Kashiba, Nara, Japan
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Niigata
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Gosen, Niigata, Japan
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Tsubame, Niigata, Japan
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Oita
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Nakatsu, Oita, Japan
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Okayama
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Kurashiki, Okayama, Japan
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Osaka
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Habikino, Osaka, Japan
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Ibaraki, Osaka, Japan
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Ikeda, Osaka, Japan
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Izumisano, Osaka, Japan
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Kaizuka, Osaka, Japan
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Kishiwada, Osaka, Japan
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Matsubara, Osaka, Japan
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Minoo, Osaka, Japan
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Motiguchi, Osaka, Japan
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Neyagawa, Osaka, Japan
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Osaka Sayama, Osaka, Japan
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Sakai, Osaka, Japan
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Suita, Osaka, Japan
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Toyonaka, Osaka, Japan
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Yao, Osaka, Japan
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Saitama
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Asagiri, Saitama, Japan
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Hidaka, Saitama, Japan
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Kawagoe, Saitama, Japan
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Koshigaya, Saitama, Japan
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Kumagaya, Saitama, Japan
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Sayama, Saitama, Japan
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Shimane
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Hamada, 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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Hamamatsu, Shizuoka, Japan
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Izu, Shizuoka, Japan
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Shimizu, Shizuoka, Japan
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Tochigi
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Ashikaga, Tochigi, Japan
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Tokushima
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Yoshinogawa, Tokushima, Japan
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Tokyo
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Adachi, Tokyo, Japan
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Arakawa, Tokyo, Japan
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Chiyoda, Tokyo, Japan
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Edogawa, Tokyo, Japan
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Itabashi, Tokyo, Japan
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Katsushika, Tokyo, Japan
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Koutou, Tokyo, Japan
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Minato, Tokyo, Japan
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Musashino, Tokyo, Japan
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Nakano, Tokyo, Japan
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Nishi Tokyo, Tokyo, Japan
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Oota, 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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Shinjyuku, 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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Toyama
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Kurobe, Toyama, Japan
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Takaoka, Toyama, Japan
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Yamagata
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Kahoku, Yamagata, Japan
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Yamanashi
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Kai, Yamanashi, Japan
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Nirasaki, Yamanashi, Japan
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Sannolikhetsprov
Studera befolkning
Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)
Beskrivning
Inclusion Criteria:
- Prostate cancer patients who have no history of receiving endocrine therapy (including surgical castration), and who plan to undergo Casodex® tablets monotherapy for not less than 12 months
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Adverse event incidence
Tidsram: Time since starting Casodex monotherapy, monthly
|
Time since starting Casodex monotherapy, monthly
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
improvement of prostate cancer using Tumor marker PSA
Tidsram: Time since starting Casodex monotherapy, monthly
|
Time since starting Casodex monotherapy, monthly
|
|
Maintenance of sexual function
Tidsram: At 3 months since starting Casodex monotherapy,
|
At 3 months since starting Casodex monotherapy,
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 maj 2009
Primärt slutförande (Faktisk)
1 mars 2012
Avslutad studie (Faktisk)
1 mars 2012
Studieregistreringsdatum
Först inskickad
11 juni 2009
Först inskickad som uppfyllde QC-kriterierna
11 juni 2009
Första postat (Uppskatta)
12 juni 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
23 januari 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
21 januari 2013
Senast verifierad
1 januari 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NIS-OJP-CAS-2009/1
- CAS002
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .