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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.

Sponsored by Laboratorios Osorio de Moraes Ltda.

About this trial

Last updated 16 years ago

Study ID

E02-OSM-AS-01-08

Status

Unknown status

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
6+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 15 years ago

What is this trial about?

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®.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status