Clinical Trial: Uncomplicated Pelvic Inflammatory Disease. Treatment With Moxifloxacin.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective, Randomized, Double-blind, Multicenter, Multinational Study Comparing Efficacy and Safety of Moxifloxacin 400 mg po od for 14 Days With Ofloxacin 400 mg po Bid Plus Metronidazole 500 mg po
Brief Summary: Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease
Detailed Summary:
Sponsor: Bayer
Current Primary Outcome: Clinical response 5 to 24 days after the last dose of study medication [ Time Frame: 5 to 24 days after the last dose ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Bacterial response at the test of cure visit and at the FU visit 28 to 42 days after last dose of study medication [ Time Frame: visit 28 to 42 days after last dose ]
- Clinical response at during-treatment visit (Day 4-7) and at follow-up 28 to 42 days after last dose [ Time Frame: (Day 4-7) and at follow-up 28 to 42 days after last dose ]
- Reduction from baseline in pain report at the different assessment visits [ Time Frame: Over the entire trial period (overall) ]
- Necessity for modifying antibiotic therapy at the during-treatment visit and TOC visit and necessity for institution of an antibiotic therapy at follow-up [ Time Frame: Over the entire trial period (overall) ]
Original Secondary Outcome: Same as current
Information By: Bayer
Dates:
Date Received: May 21, 2008
Date Started: April 2003
Date Completion:
Last Updated: October 12, 2014
Last Verified: October 2014
