Status:
COMPLETED
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
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Sinusitis
Maxillary Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 sev...
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, multic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 1993
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1994
Estimated Enrollment :
614 Patients enrolled
Trial Details
Trial ID
NCT00249210
Start Date
August 1 1993
End Date
July 1 1994
Last Update
June 10 2011
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