drugset / Trial / NCT00967317

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.

NCT00967317

Phase 3 Unknown 188 enrolled Laboratorios Osorio de Moraes Ltda.
RandomizedParallel-groupOpen-labelTreatment

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®.

Timeline

Start
2009-12
Primary completion
2010-03
Completion
2010-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Auris-Sedina Unknown
Comparator fluocinolone acetonide Small molecule Other

Indications