Clinical Trial: An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Double-Blind, Phase 3B Study to Compare the Safety and Clinical Efficacy of Levofloxacin in 750mg for 2 Weeks and Levofloxacin 750mg for 3 Weeks to That of Levofloxacin 500mg for 4 Week

Brief Summary: 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.

Detailed Summary: The optimal duration of treatment for chronic prostatitis remains unclear. Historically, therapy for chronic prostatitis with other classes of antibacterials resulted in poor outcomes and prolonged time taking the medication. Levofloxacin belongs to the quinolone class of antibacterials and has been used to treat chronic prostatitis with 500mg of levofloxacin taken orally once a day for 4 weeks. This multicenter, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance) study is designed to see if giving levofloxacin at a higher dose for shorter periods of time is safe and effective in treating chronic prostatitis. Safety analyses will involve the examination of the incidence, severity, and type of adverse events and changes in physical findings including vital signs and clinical laboratory tests. Patients will receive one of the following three dosing options: levofloxacin 750 mg orally administered once-a-day for 2 weeks followed by placebo once-a-day for two weeks for a total of 4 weeks, or levofloxacin 750 mg orally once-a-day for 3 weeks followed by placebo once-a-day for one week for a total of 4 weeks, or levofloxacin 500 mg orally once-a-day for 4 weeks.
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Current Primary Outcome: Clinical Success [ Time Frame: Posttherapy Visit (Study Day 33-36) ]

Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.


Original Primary Outcome: The primary efficacy endpoint is clinical success, defined as cured or improved at the Post-therapy Visit, summarized by treatment group. Response is based on the resolution of signs and symptoms at post-therapy.

Current Secondary Outcome:

  • Symptom Relief (Resolved) [ Time Frame: Posttherapy Visit (Study Day 33-36) ]
    Participants With Resolution of Prostatitis Signs and Symptoms; Resolution is defined as symptoms present (mild, moderate or severe) at Screening/Admission and absent (none) at the Posttherapy evaluation.
  • Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone contact at 6 weeks ]
    Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
  • Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone contact at 3 Months ]
    Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
  • Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone Contact at 6 Months ]
    Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit
  • Total NIH-CPSI Score [ Time Frame: Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) ]
    National Institute of Health-Chronic Prostatitis Symptom Index numerically rates a total score (0-43) where 0 indicates no symptoms across any of the domains (pain or discomfort, urination, quality of life).


Original Secondary Outcome: Time to symptom relief, relapse rates, and domain scores from the NIH-Chronic Prostatitis Symptom Index and the Daily Symptom Index will be collected during the course of the study and evaluated at study end.

Information By: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Dates:
Date Received: November 21, 2006
Date Started: November 2006
Date Completion:
Last Updated: September 2, 2013
Last Verified: September 2013