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Levofloxacin for Difficult-to-Treat Acute Otitis Media in Children
NCT00044473Phase 3
Key facts
- Status
- Completed
- Start
- Nov 2002
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- levofloxacin
- Conditions
- acute otitis media (AOM)
01
Overview
Phase 3, open-label, single-arm trial of levofloxacin in acute otitis media (AOM), sponsored by Johnson & Johnson. Primary endpoint: Rate of elimination of the disease-producing bacteria identified at the start of the study. Started Nov 2002; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Levofloxacin
Levofloxacin 10 mg/kg twice daily for 10 days
03
Endpoints
Primary
Rate of elimination of the disease-producing bacteria identified at the start of the study
Secondary
Physical examinations, vital sign measurements, laboratory tests, and incidence of adverse events
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