Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257062
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-18
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 infections of the skin and the supportive layers beneath the skin
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 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None