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

NCT ID: NCT00871494

Last Updated: 2011-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Inflammatory Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Azithromycin switch therapy (switch from intravenous to oral).

Group Type EXPERIMENTAL

Azithromycin

Intervention Type DRUG

The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

Interventions

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Azithromycin

The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

Intervention Type DRUG

Eligibility Criteria

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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 of uterus).

Exclusion Criteria

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.

Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Aichi-gun, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Ichinomiya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Nagoya-city Naka-ku, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Tanba-gun Fusou-chou, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Hirosaki, Aomori, Japan

Site Status

Pfizer Investigational Site

Niihama, Ehime, Japan

Site Status

Pfizer Investigational Site

Kasuga, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu-shi, Yahatanishi-ku, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Chuou-ku, Fukuoka-city, Japan

Site Status

Pfizer Investigational Site

Fukushima, Fukushima, Japan

Site Status

Pfizer Investigational Site

Takasaki, Gunma, Japan

Site Status

Pfizer Investigational Site

Takasaki-shi, Gunma, Japan

Site Status

Pfizer Investigational Site

Hakodate-shi Goryoukaku-cho, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Hakodate-shi Hon-cho, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Chuo-ku, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kounoike Shinmachi, Kagoshima-city, Japan

Site Status

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Pfizer Investigational Site

Kamigyou-ku, Kyoto-city, Japan

Site Status

Pfizer Investigational Site

Nagano, Nagano, Japan

Site Status

Pfizer Investigational Site

Suzaka-shi, Nagano, Japan

Site Status

Pfizer Investigational Site

Okayama, Okayama-city, Japan

Site Status

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Site Status

Pfizer Investigational Site

Koshigaya, Saitama, Japan

Site Status

Pfizer Investigational Site

Aoba-ku, Sendai-city, Japan

Site Status

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nakaku, Yokohama-city Kanagawa, Japan

Site Status

Pfizer Investigational Site

Fukushima, , Japan

Site Status

Countries

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Japan

References

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Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014 Jul;20(7):429-35. doi: 10.1016/j.jiac.2014.04.001. Epub 2014 Apr 29.

Reference Type DERIVED
PMID: 24787738 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661192&StudyName=Study%20Of%20Azithromycin%20Intravenous%20Formulation%20Against%20Pelvic%20Inflammatory%20Disease%20%28PID%29%20In%20Japan

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Other Identifiers

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A0661192

Identifier Type: -

Identifier Source: org_study_id