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A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00249210
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : June 10, 2011
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information
First Submitted Date  ICMJE November 4, 2005
First Posted Date  ICMJE November 7, 2005
Last Update Posted Date June 10, 2011
Study Start Date  ICMJE August 1993
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2005)
Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses
Official Title  ICMJE A Multicenter, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With Amoxicillin/Clavulanate Potassium in the Treatment of Acute Sinusitis in Adults
Brief Summary The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection 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 amoxicillin/clavulanate (500 mg/125 mg tablets by mouth every 8 hours for 10 - 14 days) in adults with rapid onset of severe inflammation/infection 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 amoxicillin/clavulanate potassium in adults with rapid onset of severe inflammation/infection of the sinuses. 500 mg tablets of levofloxacin by mouth once daily, or 500 mg/125 mg amoxicillin/clavulanate tablets by mouth every 8 hours. The duration of treatment is 10 - 14 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Sinusitis
  • Maxillary Sinusitis
Intervention  ICMJE Drug: levofloxacin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2011)
614
Original Enrollment  ICMJE
 (submitted: November 4, 2005)
490
Actual Study Completion Date  ICMJE July 1994
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of rapid onset of severe inflammation/infection of the sinuses, as indicated by: fever, headache, discharge from the nose containing pus, facial pain, or tenderness in the area of the cheek bone
  • x-ray at the start of the trial consistent with the diagnosis of severe inflammation/infection of the sinuses
  • able to take oral medications

Exclusion Criteria:

  • Patients with symptoms of sinusitis that has persisted longer than 4 weeks or who have had more than 2 previous episodes of rapid onset of severe inflammation/infection of the sinuses within 12 months prior to the trial
  • previous allergic or serious adverse reaction to similar antibiotics
  • specific blood and urine test results indicating kidney problems
  • requirement of an antibiotic medication taken internally in addition to the study drug or have taken antibiotic medication within 48 hours prior to the start of the study and have experienced improvement
  • seizure disorders or any condition requiring tranquilizers.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00249210
Other Study ID Numbers  ICMJE CR005485
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PRS Account Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Verification Date February 2011

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