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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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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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	2%

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.

Other Adverse Events

	Levofloxacin 750mg for 2 Weeks	Levofloxacin 750mg for 3 Weeks	Levofloxacin 500mg for 4 Weeks
Total, other (not including serious) adverse events
# participants affected	43	42	38
Cardiac disorders
Hypertension ^†^A # participants affected / at risk	0/81 (0.00%)	2/81 (2.47%)	1/80 (1.25%)
Gastrointestinal disorders
Nausea ^†^A # participants affected / at risk	8/81 (9.88%)	6/81 (7.41%)	2/80 (2.50%)
Diarrhoea ^†^A # participants affected / at risk	5/81 (6.17%)	5/81 (6.17%)	5/80 (6.25%)
Constipation ^†^A # participants affected / at risk	4/81 (4.94%)	1/81 (1.23%)	2/80 (2.50%)
Abdominal Pain ^†^A # participants affected / at risk	3/81 (3.70%)	1/81 (1.23%)	6/80 (7.50%)
Dyspepsia ^†^A # participants affected / at risk	3/81 (3.70%)	1/81 (1.23%)	1/80 (1.25%)
General disorders
Chest Pain ^†^A # participants affected / at risk	3/81 (3.70%)	0/81 (0.00%)	2/80 (2.50%)
Fever ^†^A # participants affected / at risk	3/81 (3.70%)	3/81 (3.70%)	1/80 (1.25%)
Back Pain ^†^A # participants affected / at risk	2/81 (2.47%)	2/81 (2.47%)	1/80 (1.25%)
Pain ^†^A # participants affected / at risk	1/81 (1.23%)	5/81 (6.17%)	2/80 (2.50%)
Fatigue ^†^A # participants affected / at risk	0/81 (0.00%)	1/81 (1.23%)	2/80 (2.50%)
Oedema Peripheral ^†^A # participants affected / at risk	0/81 (0.00%)	1/81 (1.23%)	2/80 (2.50%)
Musculoskeletal and connective tissue disorders
Myalgia ^†^A # participants affected / at risk	4/81 (4.94%)	2/81 (2.47%)	2/81 (2.47%)
Arthralgia ^†^A # participants affected / at risk	3/81 (3.70%)	3/81 (3.70%)	0/80 (0.00%)
Skeletal Pain ^†^A # participants affected / at risk	3/81 (3.70%)	1/81 (1.23%)	1/80 (1.25%)
Fascitis Plantar ^†^A # participants affected / at risk	2/81 (2.47%)	0/81 (0.00%)	0/80 (0.00%)
Nervous system disorders
Dizziness ^†^A # participants affected / at risk	9/81 (11.11%)	3/81 (3.70%)	2/80 (2.50%)
Headache ^†^A # participants affected / at risk	3/81 (3.70%)	4/81 (4.94%)	3/80 (3.75%)
Psychiatric disorders
Insomnia ^†^A # participants affected / at risk	5/81 (6.17%)	2/81 (2.47%)	3/80 (3.75%)
Reproductive system and breast disorders
Penis Disorder ^†^A # participants affected / at risk	0/81 (0.00%)	2/81 (2.47%)	0/80 (0.00%)
Respiratory, thoracic and mediastinal disorders
Sinusitis ^†^A # participants affected / at risk	0/81 (0.00%)	1/81 (1.23%)	2/80 (2.50%)
Skin and subcutaneous tissue disorders
Rash ^†^A # participants affected / at risk	1/81 (1.23%)	0/81 (0.00%)	2/80 (2.50%)
Sweating Increased ^†^A # participants affected / at risk	0/81 (0.00%)	2/81 (2.47%)	2/80 (2.50%)

^†	Indicates events were collected by systematic assessment.
^A	Term from vocabulary, WHOART 1997

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