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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00257062 |
The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with another antibiotic, ciprofloxacin, in the treatment of adults with uncomplicated infections of the skin and the supportive layers beneath the skin.
Condition | Intervention | Phase |
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Skin Diseases, Infectious |
Drug: Levofloxacin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With That of Ciprofloxacin HCl in the Treatment of Uncomplicated Skin and Skin Structure Infections in Adults |
Enrollment: | 361 |
Study Start Date: | January 1993 |
Study Completion Date: | April 1994 |
Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. This is a randomized, double-blind, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (500 mg once daily for 7 days) compared with ciprofloxacin (500 mg once every 12 hours for 10 days) in adults with uncomplicated infections of the skin and the supportive layers beneath the skin. The study consists of 3 visits: one visit for screening and enrollment, and 2 visits for assessment of safety and effectiveness (one visit on Days 3 - 5 of the study and one visit [post-therapy] 2 - 7 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 2 weeks. The primary assessments of effectiveness include the clinical response to treatment (categorized at post-therapy as cured, improved, or failed) and the microbiological response at post-therapy (the elimination of the disease-causing bacteria, categorized as eradicated, partially eradication, or persisted, determined by patient and by type of bacteria). Safety evaluations (incidence of adverse events, physical examination, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with ciprofloxacin in patients with uncomplicated infections of the skin and the supportive layers beneath the skin. One levofloxacin 500 mg tablet by mouth, once daily (and a placebo tablet once daily, 12 hours later) for 7 days, followed by one placebo tablet every 12 hours for 3 days; or one ciprofloxacin 500 mg tablet by mouth once every 12 hours for 10 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Study ID Numbers: | CR005479 |
Study First Received: | November 18, 2005 |
Last Updated: | July 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00257062 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Infectious skin diseases skin diseases bacterial skin diseases |
antibacterial agents quinolones levofloxacin |
Anti-Infective Agents Ciprofloxacin Anti-Bacterial Agents Skin Diseases, Infectious |
Skin Diseases Skin Diseases, Bacterial Ofloxacin Anti-Infective Agents, Urinary |
Communicable Diseases Anti-Infective Agents Skin Diseases Molecular Mechanisms of Pharmacological Action Ofloxacin Anti-Infective Agents, Urinary Enzyme Inhibitors Renal Agents |
Infection Pharmacologic Actions Ciprofloxacin Anti-Bacterial Agents Skin Diseases, Infectious Therapeutic Uses Nucleic Acid Synthesis Inhibitors |