An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Condition:	Prostatitis
Intervention:	Drug: levofloxacin

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

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) ]

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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) [ Posttherapy Visit (Study Day 33-36) ]

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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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:

	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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	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.
	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
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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