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A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis

Primary Purpose

Prostatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
levofloxacin
Sponsored by
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring quinolones, ciprofloxacin, levofloxacin, chronic bacterial prostatitis, inflammation, chronic prostatitis, prostatitis, prostate, antibiotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of chronic prostatitis meeting all 3 of the following criteria: 1) clinical signs and symptoms of prostatitis including tender prostate and one or more of the following: difficulty in, frequency of, or urgency of urinating, retention of urine or hesitancy in urinating, decreased urinary stream, painful ejaculation, pelvic or low back pain, pain on examination, fever or chills 2) history of chronic prostatitis defined as 1 previous episode lasting 4 weeks or 2 or more episodes during the previous 12 months And 3) laboratory evidence of prostatitis Able to take oral medications Over-the-counter medications for chronic prostatitis are continued at the same dose during the study or are discontinued before study entry Exclusion Criteria: Have taken an antibiotic similar to levofloxacin for any reason within the past 14 days Have received any medication for more than 24 hours during the past 7 days that may be effective in treating prostatitis unless there is evidence of treatment failure after 5 or more days of treatment with the other medication Have had certain surgeries during the past 6 months, including prostate surgery, surgical opening of the bladder or kidney or insertion of a permanent catheter (tube) for urination Taking any medications that may affect bladder or prostate

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Microbiologic eradication of bacteria at posttherapy visit

    Secondary Outcome Measures

    Clinical response rates based upon signs and symptoms at posttherapy and poststudy; microbiologic eradication of bacteria at poststudy; Incidence of adverse events, changes in physical examinations, vital signs, laboratory tests

    Full Information

    First Posted
    October 7, 2005
    Last Updated
    June 8, 2011
    Sponsor
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Collaborators
    PriCara, Unit of Ortho-McNeil, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00236808
    Brief Title
    A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis
    Official Title
    A Multicenter, Double-Blind Study to Compare the Safety and Efficacy of Levofloxacin to That of Ciprofloxacin in the Treatment of Chronic Prostatitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2000 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2001 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the safety and effectiveness of levofloxacin to ciprofloxacin in patients with chronic bacterial prostatitis.
    Detailed Description
    Prostatitis (an inflammation of the prostate) is the most common condition affecting the urinary system in men under 50 years of age. Symptoms of chronic (long-term) prostatitis may include urgency to urinate, frequency or difficulty in urinating or abdominal, pelvic, or rectal pain. A frequent cause of prostatitis is bacterial infection, treatable with antibiotics. This multicenter, double-blind study evaluates the safety and effectiveness of levofloxacin as compared to ciprofloxacin in patients with chronic bacterial prostatitis. Patients receive treatment with either levofloxacin or ciprofloxacin for 28 days and are evaluated during treatment and 5-12 days after the last dose of study drug (posttherapy visit), and 1 month after the last dose (poststudy visit). Patients are contacted six months after the last dose to follow up on the potential recurrence of their prostatitis. Effectiveness is assessed by measuring the ability of the study drug to eliminate bacteria causing prostatitis and to reduce the signs and symptoms of chronic prostatitis. Laboratory tests for presence of bacteria are performed throughout the study and at each visit, patients are questioned as to the relief of their symptoms. Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. The study hypothesis is that levofloxacin is at least as effective as ciprofloxacin in treating chronic bacterial prostatitis without any significant safety issues being observed. Levofloxacin 500 milligrams (mg) by mouth once daily or ciprofloxacin 500 mg by mouth twice daily for 28 days

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatitis
    Keywords
    quinolones, ciprofloxacin, levofloxacin, chronic bacterial prostatitis, inflammation, chronic prostatitis, prostatitis, prostate, antibiotic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    383 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    levofloxacin
    Primary Outcome Measure Information:
    Title
    Microbiologic eradication of bacteria at posttherapy visit
    Secondary Outcome Measure Information:
    Title
    Clinical response rates based upon signs and symptoms at posttherapy and poststudy; microbiologic eradication of bacteria at poststudy; Incidence of adverse events, changes in physical examinations, vital signs, laboratory tests

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of chronic prostatitis meeting all 3 of the following criteria: 1) clinical signs and symptoms of prostatitis including tender prostate and one or more of the following: difficulty in, frequency of, or urgency of urinating, retention of urine or hesitancy in urinating, decreased urinary stream, painful ejaculation, pelvic or low back pain, pain on examination, fever or chills 2) history of chronic prostatitis defined as 1 previous episode lasting 4 weeks or 2 or more episodes during the previous 12 months And 3) laboratory evidence of prostatitis Able to take oral medications Over-the-counter medications for chronic prostatitis are continued at the same dose during the study or are discontinued before study entry Exclusion Criteria: Have taken an antibiotic similar to levofloxacin for any reason within the past 14 days Have received any medication for more than 24 hours during the past 7 days that may be effective in treating prostatitis unless there is evidence of treatment failure after 5 or more days of treatment with the other medication Have had certain surgeries during the past 6 months, including prostate surgery, surgical opening of the bladder or kidney or insertion of a permanent catheter (tube) for urination Taking any medications that may affect bladder or prostate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
    Organizational Affiliation
    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12946763
    Citation
    Bundrick W, Heron SP, Ray P, Schiff WM, Tennenberg AM, Wiesinger BA, Wright PA, Wu SC, Zadeikis N, Kahn JB. Levofloxacin versus ciprofloxacin in the treatment of chronic bacterial prostatitis: a randomized double-blind multicenter study. Urology. 2003 Sep;62(3):537-41. doi: 10.1016/s0090-4295(03)00565-x.
    Results Reference
    result
    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=662&filename=CR005551_CSR.pdf
    Description
    A study to evaluate the safety and effectiveness of levofloxacin compared with ciprofloxacin in patients with chronic bacterial prostatitis.

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    A Study to Evaluate the Safety and Effectiveness of Levofloxacin Compared With Ciprofloxacin in Patients With Chronic Bacterial Prostatitis

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