An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatitis
Intervention: levofloxacin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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.
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.
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
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Additional Information
For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Additional information is provided at the following link;http://dailymed.nlm.nih.gov/dailymed/about.cfm For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm
Last updated: March 6, 2008
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