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Trial record 54 of 506 for:    MOXIFLOXACIN

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease

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ClinicalTrials.gov Identifier: NCT00453349
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : November 30, 2009
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pelvic Inflammatory Disease
Interventions Drug: Moxifloxacin (Avelox, BAY12-8039)
Drug: Levofloxacin & Metronidazole
Enrollment 460
Recruitment Details A total of 463 females with uncomplicated PID were enrolled on the basis of a complete evaluation (interview, medical history and physical examination and laboratory tests). 460 subjects were randomized, 412 completed study treatment (whole medication), and 384 subjects were valid for the primary efficacy analysis.
Pre-assignment Details The efficacy results in ITT are consistent with those in PP, supporting that this is a non-inferiority study and the primary efficacy population was PP not ITT. 76 subjects were excluded from primary efficacy analysis mainly due to essential data missing or invalid, violation of inclusion/exclusion criteria and insufficient duration of therapy.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Period Title: Randomized
Started 228 232
Completed 203 209
Not Completed 25 23
Reason Not Completed
Adverse Event             12             11
Lack of Efficacy             2             1
Lost to Follow-up             7             5
Protocol Violation             1             1
Withdrawal by Subject             3             5
Period Title: Reaching of Primary Endpoint (TOC)
Started 225 [1] 230 [2]
Valid for Primary Efficacy Analysis 194 190
Completed 215 [3] 219
Not Completed 10 11
Reason Not Completed
Missing information             10             11
[1]
Subjects who attended the TOC visit or at least had a clinical evaluation at TOC
[2]
i.e. the ITT population
[3]
All PP patients and ITT patients with a clinical response with no missing information
Period Title: Completed Study
Started 228 232
Completed Study Treatment 203 [1] 209 [2]
Completed 201 [3] 198 [3]
Not Completed 27 34
Reason Not Completed
Adverse Event             12             11
Lack of Efficacy             2             1
Lost to Follow-up             7             5
Protocol Violation             1             1
Withdrawal by Subject             3             5
Lost to follow up after study treatment             2             11
[1]
25 terminated prematurely
[2]
23 terminated prematurely
[3]
had follow-up assessment or alternative antibiotic assessment
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole Total
Hide Arm/Group 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 Total of all reporting groups
Overall Number of Baseline Participants 228 232 460
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 228 participants 232 participants 460 participants
35.2  (8.4) 35.4  (8.7) 35.2  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 228 participants 232 participants 460 participants
Female
228
 100.0%
232
 100.0%
460
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Microbiology recovery   [1] 
Measure Type: Number
Unit of measure:  Number of participants with pathogenes
Number Analyzed 228 participants 232 participants 460 participants
36 36 72
[1]
Measure Description: Endocervical samples were taken for culture and Polymerase Chain Reaction (PCR) tests within 48 hours prior to start of therapy. The PCR tests were repeated at TOC and Follow-up visits if the pre-therapy results were positive for Neisseria gonorrhoeae and Chlamydia trachomatis.
Total pelvic pain score (using modified McCormack score)   [1] 
Mean (Standard Deviation)
Unit of measure:  Points on a scale
Number Analyzed 228 participants 232 participants 460 participants
11.3  (3.8) 11.6  (3.8) 11.5  (3.8)
[1]
Measure Description: Modified McCormack score was used to assess the tenderness at the abdominal and pelvic examination, 0=tenderness absent, 1=tenderness described by the subject but not manifested by facial expression or muscle tone changes, 2=tenderness resulting in altered facial expression or muscle tone, 3=tenderness causing observable marked distress.
1.Primary Outcome
Title Clinical Response 7 to 14 Days After Completion of Study Drug Therapy in Per Protocol (PP) Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 194 190
Measure Type: Number
Unit of Measure: participants
Clinical cure 152 155
Clinical non-success 42 35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments The non-inferiority margin was set to 15% in the protocol. Sample size was estimated using the method as described in Farrington-Manning (STATISTICS IN MEDICINE, Vol. 9; Farrington CP, Manning G: ”Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference...”, pg.1447-1454 [1990]). Estimation was performed to achieve 90% power, based on the equivalence delta of 15%, and a clinical success rate of 87% in the per protocol population
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-10.7 to 4.9
Estimation Comments 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.
2.Secondary Outcome
Title Clinical Response 7 to 14 Days After Completion of Study Drug Therapy on Intent To Treat (ITT) Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 225 230
Measure Type: Number
Unit of Measure: participants
Clinical cure 163 171
Clinical non-success 62 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval 95%
-9.9 to 6.0
Estimation Comments 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.
3.Secondary Outcome
Title Clinical Response on Treatment for Per Protocol Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed for the per protocol population.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 188 186
Measure Type: Number
Unit of Measure: participants
Clinical Improvement 177 181
Clinical failure 11 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.2
Confidence Interval 95%
-7.4 to 0.8
Estimation Comments Mean difference denotes the difference of clinical improvement 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.
4.Secondary Outcome
Title Clinical Response on Treatment for Intent To Treat Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 225 230
Measure Type: Number
Unit of Measure: participants
Clinical improvement 166 170
Failure, indeterminate, missing 59 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval 95%
-8.1 to 7.5
Estimation Comments Mean difference denotes the difference of clinical improvement 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.
5.Secondary Outcome
Title Bacteriological Response at Test Of Cure (TOC) Visit Microbiologically Valid
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 30 26
Measure Type: Number
Unit of Measure: participants
Eradication 27 22
Persistence 3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.4
Confidence Interval 95%
-12.7 to 20.3
Estimation Comments Mean difference denotes the difference of eradication 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.
6.Secondary Outcome
Title Bacteriological Response at Test Of Cure (TOC) Visit in Intent To Treat Population With Causative Organism
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 36 34
Measure Type: Number
Unit of Measure: participants
Eradication 28 25
Persistence, indeterminate, missing 8 9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.3
Confidence Interval 95%
-19.4 to 17.6
Estimation Comments Mean difference denotes the difference of eradication 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.
7.Secondary Outcome
Title Clinical Response at Follow-up Visit on Per Protocol Population
Hide 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
Hide Outcome Measure Data
Hide Analysis 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 omitted.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 184 180
Measure Type: Number
Unit of Measure: participants
Continued clinical cure 157 158
Continued failure, clinical recurrence/relapse 27 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.5
Confidence Interval 95%
-8.6 to 4.9
Estimation Comments 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.
8.Secondary Outcome
Title Clinical Response at Follow-up Visit on Intent To Treat Population
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 225 230
Measure Type: Number
Unit of Measure: participants
Continued clinical cure 166 170
Failure, relapse, indeterminate, missing 59 60
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval 95%
-8.1 to 7.5
Estimation Comments 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.
9.Secondary Outcome
Title Bacteriological Response at Follow-up Visit Microbiologically Valid
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the follow-up visit, the bacteriological success response was classified as eradication, and recurrence/persistence as bacteriological failures.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 28 26
Measure Type: Number
Unit of Measure: participants
Eradication 23 22
Eradication with recurrence, persistence 5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -7.9
Confidence Interval 95%
-24.9 to 15.9
Estimation Comments Mean difference denotes the difference of eradication 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.
10.Secondary Outcome
Title Bacteriological Response at Follow-up Visit in Intent To Treat Population With Causative Organism
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
At the follow-up visit, the bacteriological success response was classified as Eradication, and recurrence/persistence as bacteriological failures.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 36 34
Measure Type: Number
Unit of Measure: participants
Eradication 23 23
Eradication with recurrence, persistence 13 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Moxifloxacin, Levofloxacin Plus Metronidazole
Comments 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)
Type of Statistical Test Non-Inferiority or Equivalence
Comments Sample size estimation was based on the primary efficacy variables.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.7
Confidence Interval 95%
-30.5 to 11.9
Estimation Comments Mean difference denotes the difference of eradication 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.
11.Secondary Outcome
Title Number of Subjects Who Received Alternative Medicine
Hide Description As alternative medicine any systemic antibacterial medication was considered.
Time Frame Up to 42 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
Overall Number of Participants Analyzed 194 190
Measure Type: Number
Unit of Measure: participants
Receiving alternative medicine 4 1
Not receiving alternative medicine 190 189
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Moxifloxacin Levofloxacin Plus Metronidazole
Hide Arm/Group 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
All-Cause Mortality
Moxifloxacin Levofloxacin Plus Metronidazole
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Moxifloxacin Levofloxacin Plus Metronidazole
Affected / at Risk (%) Affected / at Risk (%)
Total   3/225 (1.33%)   1/230 (0.43%) 
Gastrointestinal disorders     
Colitis * 1  1/225 (0.44%)  0/230 (0.00%) 
Infections and infestations     
Pyelonephrits acute * 1  0/225 (0.00%)  1/230 (0.43%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous * 1  1/225 (0.44%)  0/230 (0.00%) 
Skin and subcutaneous tissue disorders     
Stevens-Johnson syndrome * 1  1/225 (0.44%)  0/230 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Moxifloxacin Levofloxacin Plus Metronidazole
Affected / at Risk (%) Affected / at Risk (%)
Total   83/225 (36.89%)   94/230 (40.87%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  10/225 (4.44%)  14/230 (6.09%) 
Nausea * 1  43/225 (19.11%)  54/230 (23.48%) 
Vomiting * 1  7/225 (3.11%)  15/230 (6.52%) 
Nervous system disorders     
Dizziness * 1  39/225 (17.33%)  36/230 (15.65%) 
Psychiatric disorders     
Insomnia * 1  7/225 (3.11%)  14/230 (6.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Out of the 460 randomized subjects, 5 subjects (3 moxifloxacin subjects, 2 placebo subjects) did not receive any study medication. Only one of these patients had an adverse event (stomachache, randomized to Moxifloxacin).
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00453349     History of Changes
Other Study ID Numbers: 11981
2006-000874-56 ( EudraCT Number )
First Submitted: March 27, 2007
First Posted: March 28, 2007
Results First Submitted: September 1, 2009
Results First Posted: November 30, 2009
Last Update Posted: September 8, 2014