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An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

Primary Purpose

Prostatitis

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

About this trial

This is an interventional treatment trial for Prostatitis focused on measuring Chronic Prostatitis, Prostatitis, levofloxacin, Levaquin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

001

002

003

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinical Success
Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.

Secondary Outcome Measures

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.
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
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
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
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).

Full Information

First Posted
November 21, 2006
Last Updated
September 2, 2013
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
NCT00402688
Brief Title
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis
Keywords
Chronic Prostatitis, Prostatitis, levofloxacin, Levaquin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
001
Arm Type
Active Comparator
Arm Description
levofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Arm Title
002
Arm Type
Active Comparator
Arm Description
levofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Arm Title
003
Arm Type
Active Comparator
Arm Description
levofloxacin 500mg tablet once daily for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Intervention Description
750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Intervention Description
750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Intervention Type
Drug
Intervention Name(s)
levofloxacin
Intervention Description
500mg tablet once daily for 4 weeks.
Primary Outcome Measure Information:
Title
Clinical Success
Description
Defined as cured or improved. Response is based on the resolution of signs and symptoms at post-therapy.
Time Frame
Posttherapy Visit (Study Day 33-36)
Secondary Outcome Measure Information:
Title
Symptom Relief (Resolved)
Description
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.
Time Frame
Posttherapy Visit (Study Day 33-36)
Title
Clinical Success (Non-Relapse) or Failure (Relapse)
Description
Number of Clinical Successes or Failures at the 6-Week Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Time Frame
Poststudy Telephone contact at 6 weeks
Title
Clinical Success (Non-Relapse) or Failure (Relapse)
Description
Number of Clinical Successes or Failures at 3 Month Poststudy Telephone Contact for Participants Cured/Improved at the Posttherapy Visit
Time Frame
Poststudy Telephone contact at 3 Months
Title
Clinical Success (Non-Relapse) or Failure (Relapse)
Description
Number of Clinical Successes or Failures at the 6-month Poststudy Telephone Contact For Participants Cured/Improved at the Posttherapy Visit
Time Frame
Poststudy Telephone Contact at 6 Months
Title
Total NIH-CPSI Score
Description
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).
Time Frame
Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Organizational Affiliation
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Official's Role
Study Director
Facility Information:
City
Birmingham
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Alabama
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United States
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Homewood
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Alabama
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United States
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Anchorage
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Alaska
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Hot Springs
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Fresno
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San Diego
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Denver
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New Britain
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New Smyrna
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Ocala
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Orlando
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Ormond Beach
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Plantation
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St Petersburg
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Tallahassee
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Tampa
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Wellington
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Columbus
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Roswell
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Jeffersonville
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Indiana
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Des Moines
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Shreveport
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Louisiana
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Greenbelt
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Saint Louis
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Las Vegas
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Marlton
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Albuquerque
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New Mexico
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Garden City
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New York
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Kingston
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New York
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New York
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New York
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Orchard Park
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Poughkeepsie
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Staten Island
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New York
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Salisbury
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North Carolina
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Columbus
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Bethany
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Allentown
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United States
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Bala Cynwyd
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Pennsylvania
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United States
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State College
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Pennsylvania
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United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20394471
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=62&filename=CR012103_CSR.pdf
Description
An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis.

Learn more about this trial

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

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