Trial Condition(s):
Pelvic Inflammatory Disease
A Trial Comparing Moxifloxacin versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Bayer Identifier:
11981
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Obstetrics & Gynecology Hosp. of Fudan Univ. Shanghai, China, 200011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Univ. First Hosp. Beijing, China, 100034 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shengjing Hosp. of China Medical Univ. Shenyang, China, 110004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chung Shan Medical University Hospital Taizung, Taiwan, China, 402 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mahidol University Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University Third Hospital Beijing, China, 100083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 2nd Hosp., Chongqing Medical Univ. Chongqing, China, 400010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bunda Hospital Jakarta, Indonesia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HanYang University Medical Center Seoul, South Korea, 133792 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Philippine General Hospital Manila, Philippines | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziauddin Medical University Hospital Karachi, Pakistan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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)
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) PopulationTimeframe: 7 - 14 days after completion of study drug therapy
Secondary Outcome
- Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) PopulationTimeframe: 7 - 14 days after completion of study drug therapy
- Clinical Response on Treatment for Per Protocol PopulationTimeframe: 4 - 7 days after start of therapy
- Clinical Response on Treatment for Intent To Treat PopulationTimeframe: 4 - 7 days after start of therapy
- Bacteriological Response at Test Of Cure (TOC) visit microbiologically validTimeframe: 7 – 14 days at TOC visit
- Bacteriological Response at Test Of Cure (TOC) visit in Intent To Treat population with causative organismTimeframe: 7 – 14 days at TOC visit
- Clinical Response at follow-up visit on Per Protocol populationTimeframe: 28 – 42 days after completion of study drug therapy
- Clinical Response at follow-up visit on Intent To Treat populationTimeframe: 28 – 42 days after completion of study drug therapy
- Bacteriological Response at follow-up visit microbiologically validTimeframe: 28 – 42 days after completion of study drug therapy
- Bacteriological Response at follow-up visit in Intent To Treat population with causative organismTimeframe: 28 – 42 days after completion of study drug therapy
- Number of subjects who received alternative medicineTimeframe: up to 42 days after end of treatment
Additional Information
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