Phase 3 N=242 Randomized Triple-blind Treatment

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Prostatitis

Bottom Line

View on ClinicalTrials.gov: NCT00402688 ↗

Enrolled (actual)

242

Serious AEs

—

Results posted

Jul 2009

Primary outcome: Primary: Clinical Success — 46; 48; 52 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: levofloxacin (Drug)
Age: Adult, Older Adult · 40+ yrs
Sex: Male
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Clinical Success	46; 48; 52	—
SECONDARY Symptom Relief (Resolved)	23; 29; 27; 24; 19; 30	—
SECONDARY Clinical Success (Non-Relapse) or Failure (Relapse)	19; 19; 31; 10; 4; 6	—
SECONDARY Clinical Success (Non-Relapse) or Failure (Relapse)	19; 19; 31; 10; 4; 6	—
SECONDARY Clinical Success (Non-Relapse) or Failure (Relapse)	19; 19; 31; 10; 4; 6	—
SECONDARY Total NIH-CPSI Score	11.8; 12.0; 12.9; 7.2; 6.6; 6.9	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00402688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.