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An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00402688
First received: November 21, 2006
Last updated: May 17, 2011
Last verified: January 2011
History of Changes
Results First Received: March 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
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.
Total Total of all reporting groups

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   [ Time Frame: Posttherapy Visit (Study Day 33-36) ]
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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)   [ Time Frame: Posttherapy Visit (Study Day 33-36) ]
  Show Outcome Measure 2

3.  Secondary:   Clinical Success (Non-Relapse) or Failure (Relapse)   [ Time Frame: Poststudy Telephone contact at 6 weeks ]
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4.  Secondary:   Clinical Success (Non-Relapse) or Failure (Relapse)   [ Time Frame: Poststudy Telephone contact at 3 Months ]
  Show Outcome Measure 4

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

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


  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 by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications automatically indexed to this study:


Responsible Party: VP Medical Affairs, Ortho McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00402688     History of Changes
Other Study ID Numbers: CR012103
Study First Received: November 21, 2006
Results First Received: March 20, 2009
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration