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Clinical Trial Summary

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®.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00967317
Study type Interventional
Source Laboratorios Osorio de Moraes Ltda.
Contact Dagoberto Brandão
Phone 55 11 3673 3763
Email dagoberto@phcbrasil.com.br
Status Not yet recruiting
Phase Phase 3
Start date December 2009
Completion date April 2010

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