NCT00402688

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

A Multicenter, Double-Blind, Phase 3B Study to Compare the Safety and Clinical Efficacy of Levofloxacin in 750mg for 2 Weeks and Levofloxacin 750mg for 3 Weeks to That of Levofloxacin 500mg for 4 Weeks in the Treatment of Chronic Prostatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

Detailed description

The optimal duration of treatment for chronic prostatitis remains unclear. Historically, therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication. Levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance) study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis. Safety analyses will involve the examination of the incidence, severity, and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests. Patients will receive one of the following three dosing options: levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks, or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks, or levofloxacin 500 mg orally once-a-day for 4 weeks.

Conditions

• Prostatitis

Interventions

Type	Name	Description
DRUG	levofloxacin	750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
DRUG	levofloxacin	750mg tablet once daily for 3 weeks followed by 1 week of placebo.
DRUG	levofloxacin	500mg tablet once daily for 4 weeks.

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-03-01
• Completion: 2008-09-01
• First posted: 2006-11-22
• Last updated: 2013-09-13
• Results posted: 2009-07-16

Locations

39 sites across 1 country: United States