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| Sponsor: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Collaborator: |
PriCara, Unit of Ortho-McNeil, Inc. |
| Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| ClinicalTrials.gov Identifier: | NCT00236808 |
Purpose
The purpose of this study is to compare the safety and effectiveness of levofloxacin to ciprofloxacin in patients with chronic bacterial prostatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatitis |
Drug: levofloxacin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
| Enrollment: | 383 |
| Study Start Date: | May 2000 |
| Study Completion Date: | November 2001 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
| ClinicalTrials.gov Identifier: | NCT00236808 History of Changes |
| Other Study ID Numbers: | CR005551 |
| Study First Received: | October 7, 2005 |
| Last Updated: | June 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
quinolones, ciprofloxacin levofloxacin chronic bacterial prostatitis inflammation |
chronic prostatitis prostatitis prostate antibiotic |
|
Prostatitis Prostatic Diseases Genital Diseases, Male Ciprofloxacin Ofloxacin Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses Anti-Bacterial Agents Anti-Infective Agents, Urinary Renal Agents |