An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis - Full Text View

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00402688

Purpose

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.

Condition	Intervention	Phase
Prostatitis	Drug: levofloxacin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

Clinical Success [ Time Frame: Posttherapy Visit (Study Day 33-36) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptom Relief (Resolved) [ Time Frame: Posttherapy Visit (Study Day 33-36) ] [ Designated as safety issue: No ]
Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone contact at 6 weeks ] [ Designated as safety issue: No ]
Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone contact at 3 Months ] [ Designated as safety issue: No ]
Clinical Success (Non-Relapse) or Failure (Relapse) [ Time Frame: Poststudy Telephone Contact at 6 Months ] [ Designated as safety issue: No ]
Total NIH-CPSI Score [ Time Frame: Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36) ] [ Designated as safety issue: No ]

Enrollment:	242
Study Start Date:	November 2006
Study Completion Date:	September 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
levofloxacin 750mg for 2 weeks: Active Comparator	Drug: levofloxacin levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo
levofloxacin 750mg for 3 weeks: Active Comparator	Drug: levofloxacin levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
levofloxacin 500mg for 4 weeks: Active Comparator	Drug: levofloxacin levofloxacin, 500mg tablet once daily for 4 weeks.

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

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402688

Sponsors and Collaborators

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

No publications provided

Responsible Party:	Ortho McNeil Janssen Scientific Affairs, LLC ( VP Medical Affairs )
Study ID Numbers:	CR012103
Study First Received:	November 21, 2006
Results First Received:	March 20, 2009
Last Updated:	July 21, 2009
ClinicalTrials.gov Identifier:	NCT00402688 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Prostatitis
Levaquin
Chronic Prostatitis
levofloxacin

Additional relevant MeSH terms:

Anti-Infective Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Prostatic Diseases
Ofloxacin
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Renal Agents

Genital Diseases, Male
Pharmacologic Actions
Prostatitis
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Chronic Disease
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2009