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

• ClinicalTrials.gov Identifier: NCT00249210
• Recruitment Status: Completed
• First Posted: November 7, 2005
• Last Update Posted: June 10, 2011
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Information provided by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Tracking Information

• First Submitted Date: November 4, 2005
• First Posted Date: November 7, 2005
• Last Update Posted Date: June 10, 2011
• Study Start Date: August 1993
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Sinusitis
• Maxillary Sinusitis

• Intervention: Drug: levofloxacin
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2011): 614
• Original Enrollment (submitted: November 4, 2005): 490
• Actual Study Completion Date: July 1994
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00249210
• Other Study ID Numbers: CR005485
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborators: PriCara, Unit of Ortho-McNeil, Inc.

Investigators

• 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