Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of levofloxacin to ciprofloxacin in patients with chronic bacterial prostatitis.


Clinical Trial Description

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 ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00236808
Study type Interventional
Source Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Contact
Status Completed
Phase Phase 3
Start date May 2000
Completion date November 2001

See also
  Status Clinical Trial Phase
Completed NCT02246361 - Impact of Six Patient Information Leaflets (PIL) on Doctor Patient Communication Phase 4
Recruiting NCT00775515 - Laparoscopic Prostatectomy for Chronic Prostatitis Phase 2
Withdrawn NCT03027076 - Microbiome of Urologic Chronic Pelvic Pain Syndrome N/A
Completed NCT00402688 - An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis Phase 3
Suspended NCT00194636 - Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia) Phase 4
Recruiting NCT03720951 - Applying Pulsed Radiofrequency to the Pudendal Nerve Bilaterally Vs Its Application to Sacral Nerve Roots S2,3 and 4 Bilaterally in Chronic Prostatitis N/A
Completed NCT03879486 - Infectious Outcomes of Povidone-iodine Rectal Cleansing Plus Formalin Disinfection of Needle During Prostate Biopsy N/A
Completed NCT01676857 - Chemokine Mechanisms in Chronic Pelvic Pain
Completed NCT00169585 - Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA) Phase 3
Completed NCT00277511 - Levofloxacin, Chronic Bacterial Prostatitis Phase 3
Completed NCT01886547 - 2013 Annual National Digital Rectal Exam (DRE) Day Study N/A
Completed NCT00701311 - An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 2
Terminated NCT00194597 - Trial of Viagra' in Men With Chronic Pelvic Pain Syndrome Type III Phase 4
Completed NCT03931538 - Rapid Molecular Organism Identification and Mixed Flora Antibiotic Resistance Profiling (MixAR) Prospective Study N/A
Completed NCT00675298 - Linkage Analysis in Interstitial Cystitis N/A
Terminated NCT00529386 - Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Phase 1
Completed NCT00103402 - Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 3
Completed NCT00260637 - Efficacy Study of Acupuncture to Relieve Symptoms of Chronic Prostatitis Phase 2/Phase 3
Recruiting NCT01932645 - Etiology Study of Prostatitis
Completed NCT01826617 - Configuration of a New Prostate Disease Nomogram Predicting Prostate Biopsy Outcome N/A