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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00277511 |
Primary objective:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Prostatitis |
Drug: Levofloxacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Prospective, Multinational, Multicenter, Non-Comparative, Open Study With a 6 Months Follow-up Period to Demonstrate the Efficacy and Safety of Oral Levofloxacin 500 mg Once Daily in the Treatment of Chronic Bacterial Prostatitis (CBP) |
Estimated Enrollment: | 120 |
Study Start Date: | March 2003 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
A clinical diagnosis of chronic prostatitis as evidenced by the following criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Impaired hepatic function, as shown by:
Study ID Numbers: | HR355/3036 |
Study First Received: | January 13, 2006 |
Last Updated: | October 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00277511 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Prostatitis Anti-Infective Agents Anti-Bacterial Agents Prostatic Diseases |
Ofloxacin Anti-Infective Agents, Urinary Genital Diseases, Male |
Anti-Infective Agents Prostatic Diseases Molecular Mechanisms of Pharmacological Action Ofloxacin Enzyme Inhibitors Anti-Infective Agents, Urinary Genital Diseases, Male |
Renal Agents Pharmacologic Actions Prostatitis Anti-Bacterial Agents Therapeutic Uses Nucleic Acid Synthesis Inhibitors |