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
1 other identifier
interventional
242
1 country
39
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 21, 2006
CompletedFirst Posted
Study publicly available on registry
November 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
July 16, 2009
CompletedSeptember 13, 2013
September 1, 2013
1.3 years
November 21, 2006
March 20, 2009
September 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Symptom Relief (Resolved)
Posttherapy Visit (Study Day 33-36)
Clinical Success (Non-Relapse) or Failure (Relapse)
Poststudy Telephone contact at 6 weeks
Clinical Success (Non-Relapse) or Failure (Relapse)
Poststudy Telephone contact at 3 Months
Clinical Success (Non-Relapse) or Failure (Relapse)
Poststudy Telephone Contact at 6 Months
Total NIH-CPSI Score
Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)
Study Arms (3)
001
ACTIVE COMPARATORlevofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
002
ACTIVE COMPARATORlevofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
003
ACTIVE COMPARATORlevofloxacin 500mg tablet once daily for 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Homewood, Alabama, United States
Unknown Facility
Anchorage, Alaska, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Fresno, California, United States
Unknown Facility
San Diego, California, United States
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Denver, Colorado, United States
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New Britain, Connecticut, United States
Unknown Facility
New Smyrna Beach, Florida, United States
Unknown Facility
Ocala, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Ormond Beach, Florida, United States
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Plantation, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Wellington, Florida, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Roswell, Georgia, United States
Unknown Facility
Jeffersonville, Indiana, United States
Unknown Facility
Des Moines, Iowa, United States
Unknown Facility
Shreveport, Louisiana, United States
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Greenbelt, Maryland, United States
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St Louis, Missouri, United States
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Las Vegas, Nevada, United States
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Marlton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Garden City, New York, United States
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Kingston, New York, United States
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New York, New York, United States
Unknown Facility
Orchard Park, New York, United States
Unknown Facility
Poughkeepsie, New York, United States
Unknown Facility
Staten Island, New York, United States
Unknown Facility
Salisbury, North Carolina, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Bethany, Oklahoma, United States
Unknown Facility
Allentown, Pennsylvania, United States
Unknown Facility
Bala-Cynwyd, Pennsylvania, United States
Unknown Facility
State College, Pennsylvania, United States
Related Publications (1)
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.
PMID: 20394471DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Lead, Anti-Infective Franchise
- Organization
- Ortho-McNeil Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2006
First Posted
November 22, 2006
Study Start
November 1, 2006
Primary Completion
March 1, 2008
Study Completion
September 1, 2008
Last Updated
September 13, 2013
Results First Posted
July 16, 2009
Record last verified: 2013-09