An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Prostatitis

In brief

The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

Key facts

Study ID

NCT00402688

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

242

Starts

2006-11-01

Expected to finish

2008-09-01

Last updated by the study team

2013-09-13

Who can join

Age: 40 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males 40 years of age or older
• A clinical diagnosis of chronic prostatitis as evidenced by the following two criteria: 1. Clinical signs and symptoms of prostatitis including a soft, tender prostate without noticeable nodularity with one or more of the following signs or symptoms: painful or difficult urination, suprapubic discomfort, painful ejaculation, low back pain, perineal discomfort, urinary frequency, urinary urgency or hesitancy, decreased urinary stream, urinary retention, pain on digital rectal examination, perineal tenderness or pain, fever, chills. 2. A history of chronic prostatitis as defined as: symptomatic prostatitis - a clinical diagnosis of prostatitis having been made for at least one previous episode that lasted four weeks, or two or more episodes during the previous twelve months.

You may not qualify if…

• Any condition which may interfere with the evaluation of study drug including transurethral prostatectomy within six months of enrollment, the presence of a permanent transurethral catheter or a history of cystostomy or nephrostomy
• Taking hormone therapy
• Known prostatic carcinoma
• Allergy to levofloxacin, ofloxacin, ciprofloxacin, or other members of the quinolone class of antibacterials.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Homewood, Alabama, United States
• Study site — Anchorage, Alaska, United States
• Study site — Hot Springs, Arkansas, United States
• Study site — Fresno, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — New Britain, Connecticut, United States
• Study site — New Smyrna Beach, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Plantation, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tallahassee, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Wellington, Florida, United States
• Study site — Columbus, Georgia, United States
• Study site — Roswell, Georgia, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — Des Moines, Iowa, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Greenbelt, Maryland, United States
• Study site — St Louis, Missouri, United States
• Study site — Las Vegas, Nevada, United States

Full record on ClinicalTrials.gov

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