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levofloxacin; amoxicillin/clavulanate · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| levofloxacin; amoxicillin/clavulanate | DRUG | - |
Inclusion Criteria: * Males or females, aged \> or equal to 6 months to \< 5 years * Clinical signs and symptoms of otitis media including middle ear effusion and acute inflammation or acute purulent otorrhea * At risk for difficult to treat Acute Otitis Media (AOM) is defined as having one of the ...
This combination approach is being studied for acute otitis media, or middle ear infection, in children. The Phase 3 trial NCT00051753 evaluated levofloxacin in children with recurrent and/or persistent acute otitis media, a form of the condition that has not resolved with initial treatment.
Johnson & Johnson, which trades under the ticker JNJ, is the developer associated with this program. The company sponsored the Phase 3 study of levofloxacin in children with recurrent and/or persistent acute otitis media.
The program is in Phase 3. One Phase 3 trial, NCT00051753, has been completed, and no trials are currently active. The completed study enrolled 1,643 children aged 6 months and older with recurrent and/or persistent acute otitis media.
The program includes one completed Phase 3 trial, NCT00051753, titled Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media. It enrolled 1,643 participants, was randomized, was not double-blind, and used an uncontrolled design.
The program is investigational and remains in clinical development, with a completed Phase 3 trial in children with recurrent and/or persistent acute otitis media. No approval status for this specific combination in otitis media is established by the available development record.