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ProstatitisPhase 3NCT00402688

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

A Phase 3 study testing levofloxacin in people with Prostatitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 39 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
Prostatitis
What is being tested?
levofloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
39 sitesUnited States
Study dates
Nov 2006to Sep 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Allentown, Pennsylvania

  • Study site

    Anchorage, Alaska

  • Study site

    Bala-Cynwyd, Pennsylvania

  • Study site

    Bethany, Oklahoma

  • Study site

    Birmingham, Alabama

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Fresno, California

  • Study site

    Garden City, New York

  • Study site

    Greenbelt, Maryland

  • Study site

    Homewood, Alabama

  • Study site

    Hot Springs, Arkansas

  • Study site

    Jeffersonville, Indiana

  • Study site

    Kingston, New York

  • Study site

    Las Vegas, Nevada

  • Study site

    Marlton, New Jersey

  • Study site

    New Britain, Connecticut

  • Study site

    New Smyrna Beach, Florida

  • Study site

    New York, New York

  • Study site

    Ocala, Florida

  • Study site

    Orchard Park, New York

  • Study site

    Orlando, Florida

  • Study site

    Ormond Beach, Florida

  • Study site

    Plantation, Florida

  • Study site

    Poughkeepsie, New York

  • Study site

    Roswell, Georgia

  • Study site

    Salisbury, North Carolina

  • Study site

    San Diego, California

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    State College, Pennsylvania

  • Study site

    Staten Island, New York

  • Study site

    Tallahassee, Florida

  • Study site

    Tampa, Florida

  • Study site

    Wellington, Florida

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Prostatitis
Being tested
levofloxacin
Keywords
Chronic Prostatitis, Prostatitis, levofloxacin, Levaquin
Medical subject headings
Prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • levofloxacinDrug

    750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.

  • levofloxacinDrug

    750mg tablet once daily for 3 weeks followed by 1 week of placebo.

  • levofloxacinDrug

    500mg tablet once daily for 4 weeks.

Study groups in NCT00402688
Study groupRoleWhat they receive
001Active comparatorlevofloxacin 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
Receives: Drug: levofloxacin
002Active comparatorlevofloxacin 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
Receives: Drug: levofloxacin
003Active comparatorlevofloxacin 500mg tablet once daily for 4 weeks.
Receives: Drug: levofloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Success

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

    Measured: Posttherapy Visit (Study Day 33-36)

Secondary outcomes (5)

  1. 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.

    Measured: Posttherapy Visit (Study Day 33-36)

  2. 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

    Measured: Poststudy Telephone contact at 6 weeks

  3. 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

    Measured: Poststudy Telephone contact at 3 Months

  4. 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

    Measured: Poststudy Telephone Contact at 6 Months

  5. 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).

    Measured: Screening/Admission, On-Therapy, Week 3, Week 4, Posttherapy (Study Day 33-36)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00402688
Sponsor's protocol ID
CR012103
Other IDs
CR012103
Status last verified
Sep 2013
First submitted
21 Nov 2006
Last updated
13 Sep 2013
Data monitoring committee
No

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.

    PubMed 20394471

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levofloxacin in people with Prostatitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 39 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Success (time frame: Posttherapy Visit (Study Day 33-36)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00402688, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2013.

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