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An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis

NCT00402688 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2013-09-13

Study results available
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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.

Conditions

  • Prostatitis

Interventions

DRUG

levofloxacin

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

DRUG

levofloxacin

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

DRUG

levofloxacin

500mg tablet once daily for 4 weeks.

Sponsors & Collaborators

  • PriCara, Unit of Ortho-McNeil, Inc.

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2008-03-31
Completion
2008-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402688 on ClinicalTrials.gov