Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

Last updated: September 28, 2011
Sponsor: Pfizer
Overall Status: Completed

Phase

3

Condition

Vaginal Infection

Gynecological Infections

Reproductive Health

Treatment

N/A

Clinical Study ID

NCT00871494
A0661192
  • Ages 16-80
  • Female

Study Summary

Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.

Eligibility Criteria

Inclusion

Inclusion Criteria: Both of following symptoms should be observed.

  • Lower abdominal pain and/or lower abdominal tenderness.

  • Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa ofuterus).

Exclusion

Exclusion Criteria: Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, orketolides. Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

Study Design

Total Participants: 76
Study Start date:
May 01, 2009
Estimated Completion Date:
November 30, 2010

Connect with a study center

  • Pfizer Investigational Site

    Aichi-gun, Aichi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Ichinomiya, Aichi
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nagoya-city Naka-ku, Aichi-prefecture
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Tanba-gun Fusou-chou, Aichi-prefecture
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Hirosaki-city, Aomori-prefecture
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Niihama, Ehime
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Niihama-city, Ehime
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kitakyusyu, Fukuoka
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chuou-ku, Fukuoka-city
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kitakyushu-shi, Yahatanishi-ku, Fukuoka-ken
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kasuga-city, Fukuoka-prefecture
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Takasaki-shi, Gunma-ken
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Takasaki-city, Gunma-prefecture
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Hakodate-shi Goryoukaku-cho, Hokkaido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Hakodate-shi Hon-cho, Hokkaido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Sapporo-shi, Hokkaido
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Chuo-ku, Hyogo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kobe, Hyogo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kounoike shinmachi, Kagoshima-city
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kamigyou-ku, Kyoto-city
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Suzaka-shi, Nagano-ken
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Okayama-shi, Okayama-ken
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Koshigaya, Saitama
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Aoba-ku, Sendai-city
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Meguro-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Minato-ku, Tokyo
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Naka-ku, Yokohama-city Kanagawa
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Fukushima,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Kagoshima,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Nagano,
    Japan

    Site Not Available

  • Pfizer Investigational Site

    Okayama-city,
    Japan

    Site Not Available

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