A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis

• Status: Completed
• Trial end date: 2001-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Ciprofloxacin; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of chronic prostatitis meeting all 3 of the following criteria: 1) clinical signs and symptoms of prostatitis including tender prostate and one or more of the following: difficulty in, frequency of, or urgency of urinating, retention of urine or hesitancy in urinating, decreased urinary stream, painful ejaculation, pelvic or low back pain, pain on examination, fever or chills

• 2) history of chronic prostatitis defined as 1 previous episode lasting 4 weeks or 2 or more episodes during the previous 12 months

• And 3) laboratory evidence of prostatitis

• Able to take oral medications

• Over-the-counter medications for chronic prostatitis are continued at the same dose during the study or are discontinued before study entry

Exclusion Criteria:

• Have taken an antibiotic similar to levofloxacin for any reason within the past 14 days

• Have received any medication for more than 24 hours during the past 7 days that may be effective in treating prostatitis unless there is evidence of treatment failure after 5 or more days of treatment with the other medication

• Have had certain surgeries during the past 6 months, including prostate surgery, surgical opening of the bladder or kidney or insertion of a permanent catheter (tube) for urination

• Taking any medications that may affect bladder or prostate