To evaluate the efficacy and tolerability of Auris-Sedina in the symptomatic control of otalgy in patients with and without acute external otitis compared with use of Otosynalar®.
Phase III open Study, multicenter, prospective, randomized entrance of a total of 188 patients, 94 patients will receive medication test and 94 patients will receive Otosynalar®. Patients will be assessed until the clinical condition has been resolved or a maximum of 3 days. 188 patients of either gender or race, who have at least two of the following symptoms: pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo. And with a clinical or non-acute external otitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases. The medication should be used for a maximum of 3 days when they should return to the doctor.
Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Visual Analogic Scale, by clinical examination and opinion of the investigator.
Time frame: 3 days
Of adverse events related to study medication by the Naranjo Algorithm.
Time frame: 3 days
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