Back to resultsA Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Primary Purpose
Pelvic Inflammatory Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Moxifloxacin (Avelox, BAY12-8039)
Levofloxacin & Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Inflammatory Disease focused on measuring Uncomplicated pelvic inflammatory disease
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Moxifloxacin
Levofloxacin plus Metronidazole
Arm Description
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Outcomes
Primary Outcome Measures
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.
Secondary Outcome Measures
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".
Clinical Response on Treatment for Per Protocol Population
At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).
Clinical Response on Treatment for Intent To Treat Population
Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.
Clinical Response at Follow-up Visit on Per Protocol Population
Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.
Clinical Response at Follow-up Visit on Intent To Treat Population
All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.
Bacteriological Response at Follow-up Visit Microbiologically Valid
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Number of Subjects Who Received Alternative Medicine
As alternative medicine any systemic antibacterial medication was considered.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00453349
Brief Title
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
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 Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the efficacy and safety of oral moxifloxacin compared to oral levofloxacin plus oral metronidazole in uncomplicated pelvic inflammatory disease (PID)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Inflammatory Disease
Keywords
Uncomplicated pelvic inflammatory disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
460 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Moxifloxacin
Arm Type
Experimental
Arm Description
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Arm Title
Levofloxacin plus Metronidazole
Arm Type
Active Comparator
Arm Description
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin (Avelox, BAY12-8039)
Intervention Description
Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin & Metronidazole
Intervention Description
Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
Primary Outcome Measure Information:
Title
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Description
Clinical cure was defined as: Reduction of the tenderness score (modified McCormack) by > 70% and apyrexia (rectal/tympanic/oral temperature value < 38.0°C or axillary temperature value < 37.5°C) and white blood cell count < 10,500/mm^3.
Time Frame
7 - 14 days after completion of study drug therapy
Secondary Outcome Measure Information:
Title
Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
Description
For any subject in the ITT population also valid for the PP analysis, same clinical response as in the PP analysis was applied to the ITT analysis. For those subjects in the ITT population invalid for the PP analysis, any clinical response different from clinical cure was set to "non-success".
Time Frame
7 - 14 days after completion of study drug therapy
Title
Clinical Response on Treatment for Per Protocol Population
Description
At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement (severity score reduced by >30% with improvement in temperature, clinical failure (reduction in severity score of < or equal 30% and/or no improvement in temperature) or indeterminate (clinical assessment not possible to determine).
Time Frame
4 - 7 days after start of therapy
Title
Clinical Response on Treatment for Intent To Treat Population
Description
Clinical response during treatment was analyzed exploratively in the same way as the primary efficacy variable. At the During Therapy (Day 4 to 7) assessment, the clinical response was graded as clinical Improvement, clinical failure or indeterminate accordingly. Clinical improvement was considered success, all other outcomes as non-success.
Time Frame
4 - 7 days after start of therapy
Title
Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
Description
The bacteriological responses was based on the results of appropriate cultures taken before and, if necessary, during treatment, at the TOC visit and within the follow-up period. Bacteriological response at the TOC visit would also be based on repeated PCR tests for N. gonorrhoeae and C. trachomatis.
Time Frame
7 - 14 days at TOC visit
Title
Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
Description
Bacteriological response at the TOC was analyzed exploratively in the same way as the primary efficacy variable based on the subgroup of microbiologically valid subjects. At the TOC visit, eradication was considered a bacteriological success, and persistence, presumed persistence and superinfection were considered bacteriological failures.
Time Frame
7 - 14 days at TOC visit
Title
Clinical Response at Follow-up Visit on Per Protocol Population
Description
Clinical response at follow up was analyzed exploratively in the same way as the primary efficacy variable. At Follow-up, the clinical response was graded as continued cure, clinical relapse, or indeterminate, of which only continued cure was considered success. Failures from end of treatment were carried forward.
Time Frame
28 - 42 days after completion of study drug therapy
Title
Clinical Response at Follow-up Visit on Intent To Treat Population
Description
All successfully treated subjects and subjects evaluated as"indeterminate" at TOC, who were not administered an additional antibiotic therapy would have their clinical response rate assessed at the follow-up visit. Patients with missing or indeterminate outcome were treated as non-successes.
Time Frame
28 - 42 days after completion of study drug therapy
Title
Bacteriological Response at Follow-up Visit Microbiologically Valid
Description
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Time Frame
28 - 42 days after completion of study drug therapy
Title
Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
Description
Subjects with at least one causative organism identified in the pre-therapy culture or a positive pre-therapy PCR result and an appropriate post-therapy bacteriological evaluation available were analyzed. Bacteriological responses at follow-up visit was analyzed exploratively in the same way as the primary efficacy variable.
Time Frame
28 - 42 days after completion of study drug therapy
Title
Number of Subjects Who Received Alternative Medicine
Description
As alternative medicine any systemic antibacterial medication was considered.
Time Frame
Up to 42 days after end of treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
City
Beijing
ZIP/Postal Code
100034
Country
China
City
Beijing
ZIP/Postal Code
100083
Country
China
City
Chongqing
ZIP/Postal Code
400010
Country
China
City
Shanghai
ZIP/Postal Code
200011
Country
China
City
Jakarta
Country
Indonesia
City
Seoul
ZIP/Postal Code
133792
Country
Korea, Republic of
City
Karachi
Country
Pakistan
City
Manila
Country
Philippines
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
City
Taizung
ZIP/Postal Code
402
Country
Taiwan
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20716255
Citation
Judlin P, Liao Q, Liu Z, Reimnitz P, Hampel B, Arvis P. Efficacy and safety of moxifloxacin in uncomplicated pelvic inflammatory disease: the MONALISA study. BJOG. 2010 Nov;117(12):1475-84. doi: 10.1111/j.1471-0528.2010.02687.x. Epub 2010 Aug 18.
Results Reference
result
Learn more about this trial
A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
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