Clinical trial NCT00402688: An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
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 Weeks in the Treatment of Chronic Prostatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatitis
Keywords: Chronic Prostatitis
Prostatitis
levofloxacin
Levaquin
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: PriCara, Unit of Ortho-McNeil, Inc.
First posted: 2006-11-22
Enrollment: 242
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical Success
timeFrame: Posttherapy Visit (Study Day 33-36)
Secondary outcomes:
measure: Symptom Relief (Resolved)
timeFrame: Posttherapy Visit (Study Day 33-36)
measure: Clinical Success (Non-Relapse) or Failure (Relapse)
timeFrame: Poststudy Telephone contact at 6 weeks
measure: Clinical Success (Non-Relapse) or Failure (Relapse)
timeFrame: Poststudy Telephone contact at 3 Months
measure: Clinical Success (Non-Relapse) or Failure (Relapse)
timeFrame: Poststudy Telephone Contact at 6 Months
measure: Total NIH-CPSI Score
timeFrame: Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Homewood
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Hot Springs
country: United States
state: Arkansas
city: Fresno
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: New Britain
country: United States
state: Connecticut
city: New Smyrna
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: St Petersburg
country: United States
state: Florida
city: Tallahassee
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Wellington
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Roswell
country: United States
state: Georgia
city: Jeffersonville
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Shreveport
country: United States
state: Louisiana
city: Greenbelt
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Las Vegas
country: United States
state: Nevada
city: Marlton
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Garden City
country: United States
state: New York
city: Kingston
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Poughkeepsie
country: United States
state: New York
city: Staten Island
country: United States
state: New York
city: Salisbury
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Bethany
country: United States
state: Oklahoma
city: Allentown
country: United States
state: Pennsylvania
city: Bala Cynwyd
country: United States
state: Pennsylvania
city: State College
country: United States
state: Pennsylvania
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Paglia M, Peterson J, Fisher AC, Qin Z, Nicholson SC, Kahn JB. Safety and efficacy of levofloxacin 750 mg for 2 weeks or 3 weeks compared with levofloxacin 500 mg for 4 weeks in treating chronic bacterial prostatitis. Curr Med Res Opin. 2010 Jun;26(6):1433-41. doi: 10.1185/03007991003795030.