Prostatitis Clinical Trial
Official title:
A Multicenter, Double-Blind Study to Compare the Safety and Efficacy of Levofloxacin to That of Ciprofloxacin in the Treatment of Chronic Prostatitis
The purpose of this study is to compare the safety and effectiveness of levofloxacin to ciprofloxacin in patients with chronic bacterial prostatitis.
Prostatitis (an inflammation of the prostate) is the most common condition affecting the
urinary system in men under 50 years of age. Symptoms of chronic (long-term) prostatitis may
include urgency to urinate, frequency or difficulty in urinating or abdominal, pelvic, or
rectal pain. A frequent cause of prostatitis is bacterial infection, treatable with
antibiotics. This multicenter, double-blind study evaluates the safety and effectiveness of
levofloxacin as compared to ciprofloxacin in patients with chronic bacterial prostatitis.
Patients receive treatment with either levofloxacin or ciprofloxacin for 28 days and are
evaluated during treatment and 5-12 days after the last dose of study drug (posttherapy
visit), and 1 month after the last dose (poststudy visit). Patients are contacted six months
after the last dose to follow up on the potential recurrence of their prostatitis.
Effectiveness is assessed by measuring the ability of the study drug to eliminate bacteria
causing prostatitis and to reduce the signs and symptoms of chronic prostatitis. Laboratory
tests for presence of bacteria are performed throughout the study and at each visit,
patients are questioned as to the relief of their symptoms. Safety evaluations (incidence of
adverse events, physical examinations, laboratory tests) are performed throughout the study.
The study hypothesis is that levofloxacin is at least as effective as ciprofloxacin in
treating chronic bacterial prostatitis without any significant safety issues being observed.
Levofloxacin 500 milligrams (mg) by mouth once daily or ciprofloxacin 500 mg by mouth twice
daily for 28 days
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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