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

Pelvic Inflammatory Disease Clinical Trial

Official title:

A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871494
• Other study ID #: A0661192
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2009
• Last updated: September 28, 2011
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 80 Years

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Inflammatory Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Aichi-gun	Aichi
Japan	Pfizer Investigational Site	Aoba-ku	Sendai-city
Japan	Pfizer Investigational Site	Chuo-ku	Hyogo
Japan	Pfizer Investigational Site	Chuou-ku	Fukuoka-city
Japan	Pfizer Investigational Site	Fukushima
Japan	Pfizer Investigational Site	Hakodate-shi Goryoukaku-cho	Hokkaido
Japan	Pfizer Investigational Site	Hakodate-shi Hon-cho	Hokkaido
Japan	Pfizer Investigational Site	Hirosaki-city	Aomori-prefecture
Japan	Pfizer Investigational Site	Ichinomiya	Aichi
Japan	Pfizer Investigational Site	Kagoshima
Japan	Pfizer Investigational Site	Kamigyou-ku	Kyoto-city
Japan	Pfizer Investigational Site	Kasuga-city	Fukuoka-prefecture
Japan	Pfizer Investigational Site	Kitakyushu-shi, Yahatanishi-ku	Fukuoka-ken
Japan	Pfizer Investigational Site	Kitakyusyu	Fukuoka
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Koshigaya	Saitama
Japan	Pfizer Investigational Site	Kounoike shinmachi	Kagoshima-city
Japan	Pfizer Investigational Site	Meguro-ku	Tokyo
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Nagano
Japan	Pfizer Investigational Site	Nagoya-city Naka-ku	Aichi-prefecture
Japan	Pfizer Investigational Site	Naka-ku	Yokohama-city Kanagawa
Japan	Pfizer Investigational Site	Niihama	Ehime
Japan	Pfizer Investigational Site	Niihama-city	Ehime
Japan	Pfizer Investigational Site	Okayama-city
Japan	Pfizer Investigational Site	Okayama-shi	Okayama-ken
Japan	Pfizer Investigational Site	Sapporo-shi	Hokkaido
Japan	Pfizer Investigational Site	Suzaka-shi	Nagano-ken
Japan	Pfizer Investigational Site	Takasaki-city	Gunma-prefecture
Japan	Pfizer Investigational Site	Takasaki-shi	Gunma-ken
Japan	Pfizer Investigational Site	Tanba-gun Fusou-chou	Aichi-prefecture

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37? or Higher Was Option)	Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.; The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.	End of Treatment, Day 15 and Day 29	No
Secondary	Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37? or Higher Was Option)	Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.; The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.	End of Treatment, Day 15 and Day 29	No
Secondary	Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37? or Higher Was Option)	Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.; The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.	End of treatment, Day 15, Day 29	No
Secondary	Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37? or Higher Was Option)	Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.; The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.	End of treatment, Day 15, Day 29	No

External Links

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