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.

• Status: Unknown status
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Osorio de Moraes Ltda.

Criteria

Inclusion Criteria:

• Patients with otalgy or not, with acute external otitis ;

• Patients with at least two symptoms of otalgy (pain, discharge, tinnitus, ear fullness, subjective hearing loss temporary dizziness or vertigo) with the Visual Analogic Scale score between 4 and 8 (mild to moderate);

• The patient must present otalgia in one ear;

• Children above 6 years of age;

• Adults over 18 years of age;

• Patients who consent to participate in the study;

• Patients who are female and are of childbearing age should use reliable method of contraception and have negative pregnancy test.

Exclusion Criteria:

• Patients with sensitivity to any component of the formula;

• Patients pregnant or lactating;

• Non visualization of the tympanic membrane of obstruction by cerumen;

• Patients with evidence of any wound or scratch on the ear (ulcerative lesion);

• Patients who are making use of any other medication that might interfere with the evaluation of effectiveness of study (such as antibiotics, antiinflammatory, solutions ear);

• Patients who have severe classification in the Visual Analogic Scale score 9 or 10 in any of the symptoms listed in the questionnaire;

• Patients with otalgy not otological origin;

• Patients with otitis, except acute external otitis ;

• Patients who have epiglottitis;

• The patient with infection;

• Patients who can not follow the procedures clarified in this protocol.