Efficacy Clinical Trial
Official title:
Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control for Evaluating the Efficacy and Safety of Auris-Sedina in the Symptomatic Control of Otalgy in Patients With or Without Acute External Otitis.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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