An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
NCT ID: NCT00402688
Last Updated: 2013-09-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2006-11-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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001
levofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
levofloxacin
750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
002
levofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
levofloxacin
750mg tablet once daily for 3 weeks followed by 1 week of placebo.
003
levofloxacin 500mg tablet once daily for 4 weeks.
levofloxacin
500mg tablet once daily for 4 weeks.
Interventions
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levofloxacin
750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
levofloxacin
750mg tablet once daily for 3 weeks followed by 1 week of placebo.
levofloxacin
500mg tablet once daily for 4 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* Taking hormone therapy
* Known prostatic carcinoma
* Allergy to levofloxacin, ofloxacin, ciprofloxacin, or other members of the quinolone class of antibacterials.
40 Years
MALE
No
Sponsors
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PriCara, Unit of Ortho-McNeil, Inc.
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Birmingham, Alabama, United States
Homewood, Alabama, United States
Anchorage, Alaska, United States
Hot Springs, Arkansas, United States
Fresno, California, United States
San Diego, California, United States
Denver, Colorado, United States
New Britain, Connecticut, United States
New Smyrna Beach, 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
Columbus, Georgia, United States
Roswell, Georgia, United States
Jeffersonville, Indiana, United States
Des Moines, Iowa, United States
Shreveport, Louisiana, United States
Greenbelt, Maryland, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Marlton, New Jersey, United States
Albuquerque, New Mexico, United States
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
Salisbury, North Carolina, United States
Columbus, Ohio, United States
Bethany, Oklahoma, United States
Allentown, Pennsylvania, United States
Bala-Cynwyd, Pennsylvania, United States
State College, Pennsylvania, United States
Countries
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References
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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.
Related Links
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An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis.
Other Identifiers
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CR012103
Identifier Type: OTHER
Identifier Source: secondary_id
CR012103
Identifier Type: -
Identifier Source: org_study_id
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