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A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
This study has been completed.
Study NCT00453349   Information provided by Bayer
First Received: March 27, 2007   Last Updated: November 11, 2008   History of Changes

March 27, 2007
November 11, 2008
January 2007
May 2008   (final data collection date for primary outcome measure)
Clinical response 7 to 14 days after the completion of study drug therapy. [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]
  • TOC visit (7-14 days after EOT). The primary efficacy analysis will be performed on the per protocol population
  • Subjects will be included in the per protocol analysis if they satisfy the following criteria of a valid course
  • No other systemic antimicrobial agent (with the exception of one single dose of ceftriaxone in subjects with a gonococcal infection) was administered concomitantly with the study drug unless the subject was a treatment failure
  • The study drug was given for a minimum of 72 hours (in case of clinical failure) or 8 full days (in case of success)
  • The clinical evaluation at TOC visit must be available and different from “indeterminate”
  • The subject was not given an immunosuppressive therapy, and had no neutropenia (<1000/mm3), no HIV infection with CD4 count < 200/mm3, no AIDS-defining event, and was not under HAART
  • The diagnosis of uncomplicated pelvic inflammatory disease must have been confirmed
  • Compliance with >= 80% of study medication administered, must be documented
  • No protocol violations influencing the treatment efficacy must have been observed
  • Study blind must have been maintained.
Complete list of historical versions of study NCT00453349 on ClinicalTrials.gov Archive Site
  • Clinical response on treatment [ Time Frame: 4 to 7 days after start of treatment ] [ Designated as safety issue: Yes ]
  • Biological response at TOC visit [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]
  • Clinical response at TOC visit [ Time Frame: 7-14 days after completion of therapy ] [ Designated as safety issue: Yes ]
  • Clinical and bacteriological responses at follow-up visit [ Time Frame: 28-42 days afterend therapy ] [ Designated as safety issue: Yes ]
  • Necessity for modifying antibiotic therapy for PID [ Time Frame: from TOC up to end of follow up ] [ Designated as safety issue: Yes ]
  • Clinical response during treatment (4 to 7 days after start of treatment)
  • Bacteriological response at the TOC visit (7-14 days after the end of treatment)
  • Clinical and bacteriological response at the Follow-up visit (28 to 42 days post-therapy)
  • Clinical response at the TOC visit in subjects with bacteriologically documented infection.
 
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
A Prospective, Randomized, Double Dummy, Double Blind, Multi-Center Multinational Trial Comparing the Efficacy and Safety of Moxifloxacin 400 mg PO QD 24 Hours for 14 Days to That of Levofloxacin 500 mg PO QD 24 Hours Plus Metronidazole 500 mg BID for 14 Days in Subjects With an Uncomplicated Pelvic Inflammatory Disease. Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)

To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Pelvic Inflammatory Disease
  • Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Drug: Levofloxacin & Metronidazole
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
459
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of uncomplicated PID based on the absence of pelvic or tubo-ovarian abscess at pelvic ultrasound and/or laparoscopic examination.

Exclusion Criteria:

  • Subjects with impaired liver and renal function; known hypersensitivity to study drugs, related compounds or any of the excipients.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Indonesia,   Korea, Republic of,   Pakistan,   Philippines,   Taiwan,   Thailand
 
NCT00453349
Bayer HealthCare AG, Therapeutic Area Head
11981, EudraCT 2006-000874-56
Bayer
 
Study Director: Bayer Study Director Bayer
Bayer
November 2008

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