| Primary | 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. | The number of subjects in the PP population was slightly higher than the planned number of subjects (184 subjects per treatment group). The most common reasons for exclusion from the population valid for efficacy in both the Moxifloxacin and Comparator were essential data missing/invalid, followed by violation of inclusion/exclusion criteria. | Posted | | Number | | participants | | 7 - 14 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
| | | Title | Denominators | Categories |
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| Clinical cure | | | | Clinical non-success | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Calculated were 95% confidence intervals for the difference in success rates between treatment groups (moxifloxacin minus comparator). Method as described in Koch et al. ('Categorical Data Analysis' in Statistical methodology in the pharmaceutical sciences / edited by D. A. Berry, p. 415 ff., Marcel Dekker, 1990) | | | | | Mean Difference (Final Values) | -3.2 | | | | 95 | -10.7 | 4.9 | | | Mean difference denotes the difference of clinical cure rates in percent between the two treatment groups. A positive value indicates an advantage for the treatment group of moxifloxacin, a negative value an advantage for the comparator group. | Yes | |
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| Secondary | 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". | Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. | Posted | | Number | | participants | | 7 - 14 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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). | Analysis was performed for the per protocol population. | Posted | | Number | | participants | | 4 - 7 days after start of therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | Subjects who were randomized, had received at least one dose of study medication and had at least one observation after drug intake would be included in the ITT analysis. 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. | Posted | | Number | | participants | | 4 - 7 days after start of therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | All subjects for whom a specific bacterial pathogen was isolated/identified from any pre-treatment culture and which was considered responsible for the infection would be assessed for bacteriological efficacy. | Posted | | Number | | participants | | 7 - 14 days at TOC visit | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | Patients were included in this analysis if a causative organism could be established pre-therapy by culture or PCR, and if the patient was valid for intent-to-treat. | Posted | | Number | | participants | | 7 - 14 days at TOC visit | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | 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 omitted. | Posted | | Number | | participants | | 28 - 42 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | At the follow-up visit, the clinical response in subjects who were non-failures at the TOC visit were graded as Continued cure, Clinical relapse or Indeterminate. | Posted | | Number | | participants | | 28 - 42 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures. | Posted | | Number | | participants | | 28 - 42 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | 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. | At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures. | Posted | | Number | | participants | | 28 - 42 days after completion of study drug therapy | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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| Secondary | Number of Subjects Who Received Alternative Medicine | As alternative medicine any systemic antibacterial medication was considered. | The number of subjects who received alternative medicine in the PP population was analyzed. The clinical response was graded as alternative medicine (clinical cure, improvement, continued clinical cure) versus no alternative medicine. | Posted | | Number | | participants | | Up to 42 days after end of treatment | | | | ID | Title | Description |
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| OG000 | Moxifloxacin | Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days | | OG001 | Levofloxacin Plus Metronidazole | Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days |
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