An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

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

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.

Study Overview

• Status: Completed
• Conditions: Prostatitis
• Intervention / Treatment: Drug: levofloxacin; Drug: levofloxacin; Drug: levofloxacin

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.

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
    • Homewood, Alabama, United States
  • Alaska
    • Anchorage, Alaska, United States
  • Arkansas
    • Hot Springs, Arkansas, United States
  • California
    • Fresno, California, United States
    • San Diego, California, United States
  • Colorado
    • Denver, Colorado, United States
  • Connecticut
    • New Britain, Connecticut, United States
  • Florida
    • New Smyrna, Florida, United States
    • Ocala, Florida, United States
    • Orlando, Florida, United States
    • Ormond Beach, Florida, United States
    • Plantation, Florida, United States
    • St Petersburg, Florida, United States
    • Tallahassee, Florida, United States
    • Tampa, Florida, United States
    • Wellington, Florida, United States
  • Georgia
    • Columbus, Georgia, United States
    • Roswell, Georgia, United States
  • Indiana
    • Jeffersonville, Indiana, United States
  • Iowa
    • Des Moines, Iowa, United States
  • Louisiana
    • Shreveport, Louisiana, United States
  • Maryland
    • Greenbelt, Maryland, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Jersey
    • Marlton, New Jersey, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Garden City, New York, United States
    • Kingston, New York, United States
    • New York, New York, United States
    • Orchard Park, New York, United States
    • Poughkeepsie, New York, United States
    • Staten Island, New York, United States
  • North Carolina
    • Salisbury, North Carolina, United States
  • Ohio
    • Columbus, Ohio, United States
  • Oklahoma
    • Bethany, Oklahoma, United States
  • Pennsylvania
    • Allentown, Pennsylvania, United States
    • Bala Cynwyd, Pennsylvania, United States
    • State College, Pennsylvania, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: PriCara, Unit of Ortho-McNeil, Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

• An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 21, 2006
• First Submitted That Met QC Criteria: November 21, 2006
• First Posted (Estimate): November 22, 2006

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 2, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Chronic Prostatitis; levofloxacin; Prostatitis; Levaquin
• Additional Relevant MeSH Terms: Prostatic Diseases; Prostatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: CR012103 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)