Status:
COMPLETED
A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Oral Ciprofloxacin in the Treatment of Adults With Uncomplicated Infections of the Skin and the Supportive Layers Beneath the Skin
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Skin Diseases, Infectious
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 inf...
Detailed Description
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 e...
Eligibility Criteria
Inclusion
- Diagnosis of infection of the skin and/or the supportive layers beneath the skin, as indicated by pain at the site of the infection, redness, swelling, drainage, or other relevant clinical signs
- able to provide a sample of tissue from the affected area of the skin
- able to receive oral medications.
Exclusion
- Patients with a condition requiring treatment with antibiotics by injection into a vein, a muscle, or beneath the skin
- having a severe infection
- previous allergic or serious adverse reaction to similar antibiotics, or have severe lactose intolerance
- taken antibiotics internally within 48 hours of the start of the study with resulting improvement
- requirement of a second antibiotic taken internally or requirement of an antibiotic applied directly to the site of the infection in addition to the study drug
Key Trial Info
Start Date :
January 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1994
Estimated Enrollment :
361 Patients enrolled
Trial Details
Trial ID
NCT00257062
Start Date
January 1 1993
End Date
April 1 1994
Last Update
June 10 2011
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