Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258102
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-11-22
Brief Title:
A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections
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 That Of Lomefloxacin HCl In The Treatment Of Complicated Urinary Tract Infections In Adults
Status:
COMPLETED
Status Verified Date:
2011-01
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 the study is to compare the safety and effectiveness of oral levofloxacin an antibiotic with that of oral lomefloxacin in the treatment of complicated urinary tract infections in adults
Detailed Description:
Levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults This is a randomized open-label study of the safety and effectiveness of levofloxacin compared with lomefloxacin in the treatment of adults with complicated urinary tract infections Patients in one group are treated with 250 mg of levofloxacin taken once daily for 7 to 10 days and the other group is treated with 400 mg of lomefloxacin also an antibacterial agent taken once daily for 14 days Patients are followed for 5 to 9 days after completion of treatment post-therapy to assess clinical signs and symptoms of infection Long-term follow up 4 to 6 weeks after the end of treatment of those patients who respond to therapy provides further evaluation of clinical signs and symptoms The primary assessments of effectiveness include the clinical response the resolution of signs and symptoms at post-therapy compared with those at the start of study and the microbiological response the eradication at post-therapy of the infectious organism identified at the start of study An additional assessment of efficacy includes the overall clinical response which is described as cured improved or failed Safety assessments include the incidence of adverse events throughout the study clinical laboratory tests hematology serum chemistry and urinalysis and physical examinations at the start of the study and post-therapy The study hypothesis is that levofloxacin is at least as effective therapeutically as lomefloxacin in the treatment of adults with complicated urinary tract infections Levofloxacin tablets an oral dose of 250 mg taken once daily for 7 to 10 days Lomefloxacin tablets an oral dose of 400 mg taken once daily for 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