Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Protocol for the Specified Clinical Experience Investigation on the Single Use of Casodex® Tablet 80 mg (CAMON)

21. januar 2013 oppdatert 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).

Studieoversikt

Status

Fullført

Forhold

Studietype

Observasjonsmessig

Registrering (Faktiske)

712

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • Aichi, Japan
        • Research Site
      • Akita, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukushima, Japan
        • Research Site
      • Gifu, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Nara, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tokushima, Japan
        • Research Site
      • Tottori, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Yamagata, Japan
        • Research Site
    • Aichi
      • Houmei, Aichi, Japan
        • Research Site
      • Inuyama, Aichi, Japan
        • Research Site
      • Kasugai, Aichi, Japan
        • Research Site
      • Nagoya, Aichi, Japan
        • Research Site
      • Okazaki, Aichi, Japan
        • Research Site
      • Toyohashi, Aichi, Japan
        • Research Site
      • Toyota, Aichi, Japan
        • Research Site
    • Akita
      • Odate, Akita, Japan
        • Research Site
    • Aomori
      • Hirosaki, Aomori, Japan
        • Research Site
    • Chiba
      • Asahi, Chiba, Japan
        • Research Site
      • Funahashi, Chiba, Japan
        • Research Site
      • Ichihara, Chiba, Japan
        • Research Site
      • Ichikawa, Chiba, Japan
        • Research Site
      • Narashino, Chiba, Japan
        • Research Site
      • Sakura, Chiba, Japan
        • Research Site
    • Ehime
      • Imabari, Ehime, Japan
        • Research Site
      • Matsuyama, Ehime, Japan
        • Research Site
      • Niihama, Ehime, Japan
        • Research Site
      • Uwajima, Ehime, Japan
        • Research Site
    • Fukuoka
      • Chikushino, Fukuoka, Japan
        • Research Site
      • Iizuka, Fukuoka, Japan
        • Research Site
      • Kasuga, Fukuoka, Japan
        • Research Site
      • Kita Kyushu, Fukuoka, Japan
        • Research Site
      • Kurume, Fukuoka, Japan
        • Research Site
      • Yukuhashi, Fukuoka, Japan
        • Research Site
    • Fukushima
      • Aizuwakamatsu, Fukushima, Japan
        • Research Site
    • Gifu
      • Ibi, Gifu, Japan
        • Research Site
      • Kani, Gifu, Japan
        • Research Site
      • Minokamo, Gifu, Japan
        • Research Site
      • Mizunami, Gifu, Japan
        • Research Site
      • Ogaki, Gifu, Japan
        • Research Site
      • Seki, Gifu, Japan
        • Research Site
      • Yamagata, Gifu, Japan
        • Research Site
      • Yourou, Gifu, Japan
        • Research Site
    • Gunma
      • Isesaki, Gunma, Japan
        • Research Site
      • Kiryu, Gunma, Japan
        • Research Site
      • Numata, Gunma, Japan
        • Research Site
      • Ohta, Gunma, Japan
        • Research Site
      • Takasaki, Gunma, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
      • Eniwa, Hokkaido, Japan
        • Research Site
      • Kushiro, Hokkaido, Japan
        • Research Site
      • Sapporo, Hokkaido, Japan
        • Research Site
      • Sunagawa, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Akashi, Hyogo, Japan
        • Research Site
      • Katou, Hyogo, Japan
        • Research Site
      • Kobe, Hyogo, Japan
        • Research Site
      • Takarazuka, Hyogo, Japan
        • Research Site
    • Ibaraki
      • Hitachi, Ibaraki, Japan
        • Research Site
      • Mito, Ibaraki, Japan
        • Research Site
      • Sashima, Ibaraki, Japan
        • Research Site
      • Toride, Ibaraki, Japan
        • Research Site
      • Tsuchiura, Ibaraki, Japan
        • Research Site
    • Ishihawa
      • Hakusan, Ishihawa, Japan
        • Research Site
    • Iwate
      • Ichinoseki, Iwate, Japan
        • Research Site
      • Kamaishi, Iwate, Japan
        • Research Site
      • Miyako, Iwate, Japan
        • Research Site
      • Morioka, Iwate, Japan
        • Research Site
      • Shiwa, Iwate, Japan
        • Research Site
    • Kagawa
      • Takamatsu, Kagawa, Japan
        • Research Site
      • Zentrsuji, Kagawa, Japan
        • Research Site
    • Kagoshima
      • Minami Satsuma, Kagoshima, Japan
        • Research Site
    • Kanagawa
      • Atsugi, Kanagawa, Japan
        • Research Site
      • Chigasaki, Kanagawa, Japan
        • Research Site
      • Ebina, Kanagawa, Japan
        • Research Site
      • Kawasaki, Kanagawa, Japan
        • Research Site
      • Sagamihara, Kanagawa, Japan
        • Research Site
      • Yamato, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
      • Yokosuka, Kanagawa, Japan
        • Research Site
    • Kyoto
      • Nantan, Kyoto, Japan
        • Research Site
    • Mie
      • Inabe, Mie, Japan
        • Research Site
      • Tsu, Mie, Japan
        • Research Site
    • Miyagi
      • Matsushima, Miyagi, Japan
        • Research Site
      • Natori, Miyagi, Japan
        • Research Site
      • Sendai, Miyagi, Japan
        • Research Site
      • Shiogama, Miyagi, Japan
        • Research Site
      • Tagajo, Miyagi, Japan
        • Research Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan
        • Research Site
      • Sasebo, Nagasaki, Japan
        • Research Site
    • Nara
      • Ikoma, Nara, Japan
        • Research Site
      • Kashiba, Nara, Japan
        • Research Site
    • Niigata
      • Gosen, Niigata, Japan
        • Research Site
      • Tsubame, Niigata, Japan
        • Research Site
    • Oita
      • Nakatsu, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Osaka
      • Habikino, Osaka, Japan
        • Research Site
      • Ibaraki, Osaka, Japan
        • Research Site
      • Ikeda, Osaka, Japan
        • Research Site
      • Izumisano, Osaka, Japan
        • Research Site
      • Kaizuka, Osaka, Japan
        • Research Site
      • Kishiwada, Osaka, Japan
        • Research Site
      • Matsubara, Osaka, Japan
        • Research Site
      • Minoo, Osaka, Japan
        • Research Site
      • Motiguchi, Osaka, Japan
        • Research Site
      • Neyagawa, Osaka, Japan
        • Research Site
      • Osaka Sayama, Osaka, Japan
        • Research Site
      • Sakai, Osaka, Japan
        • Research Site
      • Suita, Osaka, Japan
        • Research Site
      • Toyonaka, Osaka, Japan
        • Research Site
      • Yao, Osaka, Japan
        • Research Site
    • Saitama
      • Asagiri, Saitama, Japan
        • Research Site
      • Hidaka, Saitama, Japan
        • Research Site
      • Kawagoe, Saitama, Japan
        • Research Site
      • Koshigaya, Saitama, Japan
        • Research Site
      • Kumagaya, Saitama, Japan
        • Research Site
      • Sayama, Saitama, Japan
        • Research Site
    • Shimane
      • Hamada, Shimane, Japan
        • Research Site
    • Shizuoka
      • Fuji, Shizuoka, Japan
        • Research Site
      • Fujieda, Shizuoka, Japan
        • Research Site
      • Hamamatsu, Shizuoka, Japan
        • Research Site
      • Izu, Shizuoka, Japan
        • Research Site
      • Shimizu, Shizuoka, Japan
        • Research Site
    • Tochigi
      • Ashikaga, Tochigi, Japan
        • Research Site
    • Tokushima
      • Yoshinogawa, Tokushima, Japan
        • Research Site
    • Tokyo
      • Adachi, Tokyo, Japan
        • Research Site
      • Arakawa, Tokyo, Japan
        • Research Site
      • Chiyoda, Tokyo, Japan
        • Research Site
      • Edogawa, Tokyo, Japan
        • Research Site
      • Itabashi, Tokyo, Japan
        • Research Site
      • Katsushika, Tokyo, Japan
        • Research Site
      • Koutou, Tokyo, Japan
        • Research Site
      • Minato, Tokyo, Japan
        • Research Site
      • Musashino, Tokyo, Japan
        • Research Site
      • Nakano, Tokyo, Japan
        • Research Site
      • Nishi Tokyo, Tokyo, Japan
        • Research Site
      • Oota, Tokyo, Japan
        • Research Site
      • Ota, Tokyo, Japan
        • Research Site
      • Setagaya, Tokyo, Japan
        • Research Site
      • Shibuya, Tokyo, Japan
        • Research Site
      • Shinagawa, Tokyo, Japan
        • Research Site
      • Shinjyuku, Tokyo, Japan
        • Research Site
      • Sumida, Tokyo, Japan
        • Research Site
      • Tachikawa, Tokyo, Japan
        • Research Site
      • Toshima, Tokyo, Japan
        • Research Site
    • Toyama
      • Kurobe, Toyama, Japan
        • Research Site
      • Takaoka, Toyama, Japan
        • Research Site
    • Yamagata
      • Kahoku, Yamagata, Japan
        • Research Site
    • Yamanashi
      • Kai, Yamanashi, Japan
        • Research Site
      • Nirasaki, Yamanashi, Japan
        • Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

Prostate cancer patients who have no history of having received treatment by either endocrine therapy (including surgical castration)

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Adverse event incidence
Tidsramme: Time since starting Casodex monotherapy, monthly
Time since starting Casodex monotherapy, monthly

Sekundære resultatmål

Resultatmål
Tidsramme
improvement of prostate cancer using Tumor marker PSA
Tidsramme: Time since starting Casodex monotherapy, monthly
Time since starting Casodex monotherapy, monthly
Maintenance of sexual function
Tidsramme: At 3 months since starting Casodex monotherapy,
At 3 months since starting Casodex monotherapy,

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2009

Primær fullføring (Faktiske)

1. mars 2012

Studiet fullført (Faktiske)

1. mars 2012

Datoer for studieregistrering

Først innsendt

11. juni 2009

Først innsendt som oppfylte QC-kriteriene

11. juni 2009

Først lagt ut (Anslag)

12. juni 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. januar 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. januar 2013

Sist bekreftet

1. januar 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NIS-OJP-CAS-2009/1
  • CAS002

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere