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 Bid for 14 Days in Patients With Uncomplicated Pelvic Inflammatory Disease (PID)”

Comparison of various antibiotics in treatment of uncomplicated pelvic inflammatory disease

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Ofloxacin
  • Ofloxacin 400 mg po bid plus metronidazole 500 mg po bid for 14 days
• Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Moxifloxacin 400 mg po od for 14 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Arm 1
• Experimental: Arm 2

Primary Measures

• Clinical response 5 to 24 days after the last dose of study medication
  • Time Frame: 5 to 24 days after the last dose
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Reduction from baseline in pain report at the different assessment visits
  • Time Frame: Over the entire trial period (overall)
    Safety Issue?: No
• 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)
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of PID based on: pelvic discomfort
• Direct lower abdominal tenderness;
• Adnexal tenderness on bimanual vaginal examination,
• Temperature > 38.0°C;
• Elevated C-reactive protein value (CRP);
• Signed PIC/IC

Exclusion Criteria:

• Pregnancy
• Abnormal lab values

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683865

Study ID Number: 10995

ClinicalTrials.gov Identifier: NCT00683865

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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