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 on November 21, 2006. Last Updated on May 17, 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

Hide Participant Flow

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

Hide 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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

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 ]

Show Outcome Measure 3

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

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
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:

Paglia M, Peterson J, Fisher AC, Qin Z, Nicholson SC, Kahn JB. Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis. Curr Med Res Opin. 2010 Jun;26(6):1433-41.

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