Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236808
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the safety and effectiveness of levofloxacin to ciprofloxacin in patients with chronic bacterial prostatitis
Detailed 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
Levofloxacin 500 milligrams mg by mouth once daily or ciprofloxacin 500 mg by mouth twice daily for 28 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None