Status:
COMPLETED
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Lead Sponsor:
Pfizer
Conditions:
Pelvic Inflammatory Disease
Eligibility:
FEMALE
16-80 years
Phase:
PHASE3
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 i...
Eligibility Criteria
Inclusion
- 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
- Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
- Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00871494
Start Date
May 1 2009
End Date
November 1 2010
Last Update
November 3 2011
Active Locations (31)
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1
Pfizer Investigational Site
Aichi-gun, Aichi-ken, Japan
2
Pfizer Investigational Site
Ichinomiya, Aichi-ken, Japan
3
Pfizer Investigational Site
Nagoya-city Naka-ku, Aichi-ken, Japan
4
Pfizer Investigational Site
Tanba-gun Fusou-chou, Aichi-ken, Japan