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

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

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

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

Symptom Relief (Resolved) [ Posttherapy Visit (Study Day 33-36) ]

Show Outcome Measure 2

3. Secondary:

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

Show Outcome Measure 3

4. Secondary:

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

Show Outcome Measure 4

5. Secondary:

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

Show Outcome Measure 5

6. Secondary:

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

Show Outcome Measure 6