Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
NCT00871494
Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Nagoya-city Naka-ku, Aichi-prefecture
- Tanba-gun Fusou-chou, Aichi-prefecture
- Aichi-gun, Aichi
- Ichinomiya, Aichi
- Hirosaki-city, Aomori-prefecture
- Niihama-city, Ehime
- Niihama, Ehime
- Chuou-ku, Fukuoka-city
- Kitakyushu-shi, Yahatanishi-ku, Fukuoka-ken
- Kasuga-city, Fukuoka-prefecture
- Kitakyusyu, Fukuoka
- Takasaki-shi, Gunma-ken
- Takasaki-city, Gunma-prefecture
- Hakodate-shi Goryoukaku-cho, Hokkaido
- Hakodate-shi Hon-cho, Hokkaido
- Sapporo-shi, Hokkaido
- Chuo-ku, Hyogo
- Kobe, Hyogo
- Kounoike shinmachi, Kagoshima-city
- Kamigyou-ku, Kyoto-city
- Suzaka-shi, Nagano-ken
- Okayama-shi, Okayama-ken
- Koshigaya, Saitama
- Aoba-ku, Sendai-city
- Meguro-ku, Tokyo
- Minato-ku, Tokyo
- Naka-ku, Yokohama-city Kanagawa
- Fukushima,
- Kagoshima,
- Nagano,
- 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 | 76 | |||
| Original Estimated Enrollment ICMJE | 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.
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 |
| |||
| 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 |
| |||
| 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 | ||||