A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pelvic Inflammatory Disease
Intervention: Moxifloxacin (Avelox, BAY12-8039) (Drug); Levofloxacin & Metronidazole (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus
oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
Clinical Details
Official title: 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 (PID). Moxifloxacin, Metronidazole, and Levofloxacin in Asia (MONALISA Study)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Secondary outcome: Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) PopulationClinical Response on Treatment for Per Protocol Population Clinical Response on Treatment for Intent To Treat Population Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism Clinical Response at Follow-up Visit on Per Protocol Population Clinical Response at Follow-up Visit on Intent To Treat Population Bacteriological Response at Follow-up Visit Microbiologically Valid Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism Number of Subjects Who Received Alternative Medicine
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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.
Locations and Contacts
Beijing 100034, China
Beijing 100083, China
Chongqing 400010, China
Shanghai 200011, China
Jakarta, Indonesia
Seoul 133792, Korea, Republic of
Karachi, Pakistan
Manila, Philippines
Taipei 10002, Taiwan
Taizung 402, Taiwan
Bangkok 10700, Thailand
Shenyang, Liaoning 110004, China
Chengdu, Sichuan 610041, China
Additional Information
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Starting date: January 2007
Last updated: September 2, 2014
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