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An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
This study has been completed.
Study NCT00402688   Information provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
First Received: November 21, 2006   Last Updated: July 21, 2009   History of Changes
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition: Prostatitis
Intervention: Drug: levofloxacin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Participant Flow:   Overall Study
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
STARTED   81     81     80  
COMPLETED   60     65     65  
NOT COMPLETED   21     16     15  
      Adverse Event               12                 9                 3  
      Withdrawal by Subject               3                 1                 1  
      Physician Decision               0                 0                 1  
      Lack of Efficacy               4                 4                 5  
      Protocol Violation               1                 1                 1  
      Lost to Follow-up               1                 0                 2  
      Culture Show Flouroquinolone Resistance               0                 1                 0  
      Urine Cult. Yield Resistant to Levaquin               0                 0                 1  
      Patient Left Town and Forgot Medication               0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Baseline Measures
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks Total
Number of Participants  
[units: participants]
 		81 81 80 242
Age  
[units: participants]
 		       
<=18 years 0 0 0 0
Between 18 and 65 years 65 71 65 201
>=65 years 16 10 15 41
Gender  
[units: participants]
 		       
Female 0 0 0 0
Male 81 81 80 242



  Outcome Measures
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1.  Primary:   Clinical Success   [ Posttherapy Visit (Study Day 33-36) ]

Measure Type Primary
Measure Title Clinical Success
Measure Description Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.
Time Frame Posttherapy Visit (Study Day 33-36)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		73 74 75
Clinical Success
[units: Participants]
 		46 48 52


Statistical Analysis 1 for Clinical Success
Groups [1] Levofloxacin 750mg for 2 Weeks vs. Levofloxacin 500mg for 4 Weeks
Non-Inferiority/Equivalence Test [2] Yes
Risk Difference (RD) [3] 0.063
95% Confidence Interval ( -0.089 to 0.215 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin is a risk difference of 0.2.
[3] Other relevant estimation information:
  Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 2 weeks ).

Statistical Analysis 2 for Clinical Success
Groups [1] Levofloxacin 750mg for 3 Weeks vs. Levofloxacin 500mg for 4 Weeks
Non-Inferiority/Equivalence Test [2] Yes
Risk Difference (RD) [3] 0.045
95% Confidence Interval ( -0.106 to 0.195 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  Non-inferiority margin is a risk difference of 0.2.
[3] Other relevant estimation information:
  Difference in success rates (levofloxacin 500mg for 4 weeks minus levofloxacin 750mg for 3 weeks).



2.  Secondary:   Symptom Relief (Resolved)   [ Posttherapy Visit (Study Day 33-36) ]

Measure Type Secondary
Measure Title Symptom Relief (Resolved)
Measure Description Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.
Time Frame Posttherapy Visit (Study Day 33-36)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		73 74 75
Symptom Relief (Resolved)
[units: Participants]
 		     
Dysuria (n=35, 43, 42) 23 29 27
Suprapubic discomfort (n=41, 36, 45) 24 19 30
Painful ejaculation (n=32, 39, 34) 17 23 20
Low back pain (n=43, 44, 44) 20 22 26
Perineal discomfort (n=40, 42, 50) 20 19 29
Frequency (n=58, 63, 62) 29 24 30
Urgency (n=48, 52, 58) 20 28 35
Hesitancy (n=37, 39, 54) 19 16 38
Decreased urinary stream (n=50, 47, 52) 24 21 30
Urinary retention (n=24, 26, 27) 13 13 17
Pain on digital rectal examination (n=60, 59, 61) 30 30 42
Perineal tenderness or pain (n=44, 38, 43) 28 24 28
Chills (n=4, 5, 7) 3 3 7
Other (n=5, 8, 8) 1 5 5
Fever (n=3, 2, 1) 2 2 1

No statistical analysis provided for Symptom Relief (Resolved)



3.  Secondary:   Clinical Success (Non-Relapse) or Failure (Relapse)   [ Poststudy Telephone contact at 6 weeks ]

Measure Type Secondary
Measure Title Clinical Success (Non-Relapse) or Failure (Relapse)
Measure Description Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Time Frame Poststudy Telephone contact at 6 weeks  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent-to-Treat Population (mITT) (Participants Cured/Improved at the Posttherapy Visit)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		46 48 52
Clinical Success (Non-Relapse) or Failure (Relapse)
[units: participants]
 		     
Clinical Success 38 32 44
Failure 3 12 5
Unable to Evaluate 0 1 1
Missing 5 3 2

No statistical analysis provided for Clinical Success (Non-Relapse) or Failure (Relapse)



4.  Secondary:   Clinical Success (Non-Relapse) or Failure (Relapse)   [ Poststudy Telephone contact at 3 Months ]

Measure Type Secondary
Measure Title Clinical Success (Non-Relapse) or Failure (Relapse)
Measure Description Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Time Frame Poststudy Telephone contact at 3 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		46 48 52
Clinical Success (Non-Relapse) or Failure (Relapse)
[units: Participants]
 		     
Clinical Success 30 24 38
Failure 8 6 4
Unable to Evaluate 0 1 1
Missing 8 17 9

No statistical analysis provided for Clinical Success (Non-Relapse) or Failure (Relapse)



5.  Secondary:   Clinical Success (Non-Relapse) or Failure (Relapse)   [ Poststudy Telephone Contact at 6 Months ]

Measure Type Secondary
Measure Title Clinical Success (Non-Relapse) or Failure (Relapse)
Measure Description Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit
Time Frame Poststudy Telephone Contact at 6 Months  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT) (Participants Cured/Improved at the Posttherapy Visit)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		46 48 52
Clinical Success (Non-Relapse) or Failure (Relapse)
[units: Participants]
 		     
Clinical Success 19 19 31
Failure 10 4 6
Unable to Evaluate 1 1 1
Missing 16 24 14

No statistical analysis provided for Clinical Success (Non-Relapse) or Failure (Relapse)



6.  Secondary:   Total NIH-CPSI Score   [ Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) ]

Measure Type Secondary
Measure Title Total NIH-CPSI Score
Measure Description National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).
Time Frame Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Modified Intent to Treat (mITT)

Reporting Groups
  Description
Levofloxacin 750mg for 2 Weeks levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Levofloxacin 750mg for 3 Weeks levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Levofloxacin 500mg for 4 Weeks levofloxacin, 500mg tablet once daily for 4 weeks.

Measured Values
  Levofloxacin 750mg for 2 Weeks Levofloxacin 750mg for 3 Weeks Levofloxacin 500mg for 4 Weeks
Number of Participants Analyzed
[units: participants] 		73 74 75
Total NIH-CPSI Score
[units: Score on a scale]
Mean ( Full Range ) 		     
Screening/Admission (n=73, 74, 75) 11.8
( 2 to 27 )		 12.0
( 3 to 27 )		 12.9
( 3 to 27 )
On-Therapy (n=70, 70, 73) 7.2
( 0 to 22 )		 6.6
( 0 to 19 )		 6.9
( 0 to 19 )
Week 3 (Visit 2) (n=62, 65, 68) 6.5
( 0 to 24 )		 6.5
( 0 to 21 )		 5.6
( 0 to 24 )
Week 4 (Visit 3) (n=53, 57, 61) 5.1
( 0 to 19 )		 4.9
( 0 to 17 )		 4.5
( 0 to 25 )
Posttherapy (Visit 4) (n=70, 71, 71) 5.4
( 0 to 24 )		 5.0
( 0 to 21 )		 4.6
( 0 to 22 )

No statistical analysis provided for Total NIH-CPSI Score




  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Therapeutic Area Lead, Anti-Infective Franchise
Organization: Ortho-McNeil Janssen Scientific Affairs, LLC
phone: 908-927-5220


No publications provided


Responsible Party: Ortho McNeil Janssen Scientific Affairs, LLC ( VP Medical Affairs )
Study ID Numbers: CR012103
Study First Received: November 21, 2006
Results First Received: March 20, 2009
Last Updated: July 21, 2009
ClinicalTrials.gov Identifier: NCT00402688     History of Changes
Health Authority: United States: Food and Drug Administration





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