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

NCT00871494

Last updated date
Study Location
Pfizer Investigational Site
Nagoya-city Naka-ku, Aichi-prefecture, , Japan
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pelvic Inflammatory Disease
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
16-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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


Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

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Pelvic Inflammatory DiseaseStudy Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan NCT00871494
  1. Nagoya-city Naka-ku, Aichi-prefecture
  2. Tanba-gun Fusou-chou, Aichi-prefecture
  3. Aichi-gun, Aichi
  4. Ichinomiya, Aichi
  5. Hirosaki-city, Aomori-prefecture
  6. Niihama-city, Ehime
  7. Niihama, Ehime
  8. Chuou-ku, Fukuoka-city
  9. Kitakyushu-shi, Yahatanishi-ku, Fukuoka-ken
  10. Kasuga-city, Fukuoka-prefecture
  11. Kitakyusyu, Fukuoka
  12. Takasaki-shi, Gunma-ken
  13. Takasaki-city, Gunma-prefecture
  14. Hakodate-shi Goryoukaku-cho, Hokkaido
  15. Hakodate-shi Hon-cho, Hokkaido
  16. Sapporo-shi, Hokkaido
  17. Chuo-ku, Hyogo
  18. Kobe, Hyogo
  19. Kounoike shinmachi, Kagoshima-city
  20. Kamigyou-ku, Kyoto-city
  21. Suzaka-shi, Nagano-ken
  22. Okayama-shi, Okayama-ken
  23. Koshigaya, Saitama
  24. Aoba-ku, Sendai-city
  25. Meguro-ku, Tokyo
  26. Minato-ku, Tokyo
  27. Naka-ku, Yokohama-city Kanagawa
  28. Fukushima,
  29. Kagoshima,
  30. Nagano,
  31. Okayama-city,
Female
16 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Inflammatory Disease
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Azithromycin switch therapy (switch from intravenous to oral).
Intervention: Drug: Azithromycin
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2010)
76
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2009)
60
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00871494
Other Study ID Numbers  ICMJE A0661192
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP