The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
493
1 vial into the affected ear twice daily for 7 days
1 vial into the affected ear twice daily for 7 days
1 vial into the affected ear twice daily for 7 days
Laboratorios SALVAT
Esplugues de Llobregat, Spain
Therapeutic Cure (Clinical + Microbiological Cure)
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Time frame: End of Treatment (Day 8+2)
Time to End of Pain
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Time frame: From baseline to End of Study (Day 15+2)
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