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

Primary Purpose

Pelvic Inflammatory Disease

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Azithromycin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Inflammatory Disease

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Azithromycin switch therapy (switch from intravenous to oral).

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 27, 2009
Last Updated
September 28, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00871494
Brief Title
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azithromycin switch therapy (switch from intravenous to oral).
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Azithromycin
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
End of Treatment, Day 15 and Day 29
Secondary Outcome Measure Information:
Title
Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Description
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.
Time Frame
End of Treatment, Day 15 and Day 29
Title
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)
Description
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.
Time Frame
End of treatment, Day 15, Day 29
Title
Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Description
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.
Time Frame
End of treatment, Day 15, Day 29

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Nagoya-city Naka-ku
State/Province
Aichi-prefecture
Country
Japan
Facility Name
Pfizer Investigational Site
City
Tanba-gun Fusou-chou
State/Province
Aichi-prefecture
Country
Japan
Facility Name
Pfizer Investigational Site
City
Aichi-gun
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Ichinomiya
State/Province
Aichi
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hirosaki-city
State/Province
Aomori-prefecture
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niihama-city
State/Province
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Niihama
State/Province
Ehime
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuou-ku
State/Province
Fukuoka-city
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyushu-shi, Yahatanishi-ku
State/Province
Fukuoka-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasuga-city
State/Province
Fukuoka-prefecture
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kitakyusyu
State/Province
Fukuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki-shi
State/Province
Gunma-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Takasaki-city
State/Province
Gunma-prefecture
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hakodate-shi Goryoukaku-cho
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hakodate-shi Hon-cho
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Pfizer Investigational Site
City
Chuo-ku
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kounoike shinmachi
State/Province
Kagoshima-city
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kamigyou-ku
State/Province
Kyoto-city
Country
Japan
Facility Name
Pfizer Investigational Site
City
Suzaka-shi
State/Province
Nagano-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama-shi
State/Province
Okayama-ken
Country
Japan
Facility Name
Pfizer Investigational Site
City
Koshigaya
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Aoba-ku
State/Province
Sendai-city
Country
Japan
Facility Name
Pfizer Investigational Site
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato-ku
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Naka-ku
State/Province
Yokohama-city Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fukushima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kagoshima
Country
Japan
Facility Name
Pfizer Investigational Site
City
Nagano
Country
Japan
Facility Name
Pfizer Investigational Site
City
Okayama-city
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24787738
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661192&StudyName=Study%20Of%20Azithromycin%20Intravenous%20Formulation%20Against%20Pelvic%20Inflammatory%20Disease%20%28PID%29%20In%20Japan
Description
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Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

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