Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00249210
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-04
Brief Title:
A Study of the Safety and Effectiveness of Levofloxacin Compared With AmoxicillinClavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe InflammationInfection of the Sinuses
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Multicenter Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With AmoxicillinClavulanate Potassium in the Treatment of Acute Sinusitis in Adults
Status:
COMPLETED
Status Verified Date:
2011-02
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 amoxicillinclavulanate potassium in the treatment of adults with rapid onset of severe inflammationinfection of the sinuses
Detailed Description:
Levofloxacin is an antibacterial agent used for the treatment of many types of severe infections with rapid onset and brief duration in adults This is a randomized open-label parallel group multicenter study to determine the safety and effectiveness of levofloxacin 500 mg tablets once daily by mouth for 10 - 14 days compared with amoxicillinclavulanate 500 mg125 mg tablets by mouth every 8 hours for 10 - 14 days in adults with rapid onset of severe inflammationinfection of the sinuses The study consists of 4 visits one visit for screening and enrollment and three visits to assess the safety and effectiveness of treatment one telephone contact during Days 3 - 6 of the study if no significant improvement in symptoms has occurred by that time a visit is scheduled one visit post-therapy 2 - 5 days after the last dose of the study drug and one visit post-study 28 - 32 days after the last dose of the study drug The total duration of patient participation in the study is approximately 6 weeks The primary measure of effectiveness is assessed by the clinical response rate after the completion of treatment a reduction in the signs and symptoms and by stabilization or improvement in x-ray findings 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 amoxicillinclavulanate potassium in adults with rapid onset of severe inflammationinfection of the sinuses 500 mg tablets of levofloxacin by mouth once daily or 500 mg125 mg amoxicillinclavulanate tablets by mouth every 8 hours The duration of treatment is 10 - 14 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