Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Prostatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2001
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00236808
Start Date
May 1 2000
End Date
November 1 2001
Last Update
June 10 2011
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