Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00258102
First received: November 22, 2005
Last updated: June 8, 2011
Last verified: January 2011

November 22, 2005
June 8, 2011
January 1993
Not Provided
Clinical response, the resolution of signs and symptoms at post-therapy compared with those at start of study; Microbiological response, the eradication at post-therapy of infectious organism identified at start of study.
Same as current
Complete list of historical versions of study NCT00258102 on ClinicalTrials.gov Archive Site
Overall clinical response, described as cured, improved, or failed; incidence of adverse events throughout the study; change in clinical laboratory tests and physical examinations from start of study to post-therapy.
Same as current
Not Provided
Not Provided
 
A Study of the Safety and Effectiveness of Levofloxacin Compared With Lomefloxacin in the Treatment of Complicated Urinary Tract Infections
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Urinary Tract Infections
  • Bacterial Infections
  • Bacteriuria
  • Urologic Diseases
Drug: Levofloxacin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
603
January 1995
Not Provided

Inclusion Criteria:

  • Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities
  • capable of taking medication by mouth
  • previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection.

Exclusion Criteria:

  • Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle
  • complete obstruction of any part of the urinary tract
  • previous allergic or serious adverse reaction to similar antibiotics
  • inflammation of the prostate gland
  • pregnant or nursing females, or those lacking adequate contraception.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00258102
CR005488
Not Provided
Not Provided
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PriCara, Unit of Ortho-McNeil, Inc.
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP