An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Study Overview
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Brief Summary
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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 Description
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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.

Official Title
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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 Weeks in the Treatment of Chronic Prostatitis

Conditions
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Prostatitis

Intervention / Treatment
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* Drug: levofloxacin
* Drug: levofloxacin
* Drug: levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 001<br>levofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo. | Drug: levofloxacin<br>* 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.<br>|
| Active Comparator: 002<br>levofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo. | Drug: levofloxacin<br>* 750mg tablet once daily for 3 weeks followed by 1 week of placebo.<br>|
| Active Comparator: 003<br>levofloxacin 500mg tablet once daily for 4 weeks. | Drug: levofloxacin<br>* 500mg tablet once daily for 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success | Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy. | Posttherapy Visit (Study Day 33-36) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom Relief (Resolved) | 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. | Posttherapy Visit (Study Day 33-36) | 
| Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit | Poststudy Telephone contact at 6 weeks | 
| Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit | Poststudy Telephone contact at 3 Months | 
| Clinical Success (Non-Relapse) or Failure (Relapse) | Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit | Poststudy Telephone Contact at 6 Months | 
| Total NIH-CPSI Score | 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). | Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levofloxacin, Chronic Prostatitis, Prostatitis, Levaquin