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.

Phase 3

• Conditions: Otitis; Efficacy; Tolerability
• Interventions: Drug: Otosynalar®; Drug: Auris-Sedina

• Registration Number: NCT00967317
• Lead Sponsor: Laboratorios Osorio de Moraes Ltda.

Brief 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®.

Detailed 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 Timeline

• Status Verified: 2009-08
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Last Update Submitted: 2009-08-25
• Study First Posted: 2009-08-27
• Last Update Posted: 2009-08-27
• Study Start: 2009-12
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Otosynalar®	Otosynalar®	Drip 3 drops in the ear 2 times a day. The medication should be used by more than 3 days after which the patient must return to the doctor.
Auris-Sedina	Auris-Sedina	Drip 2 drops of the medication with the head tilted and protect with a cotton swab. Repeat the process one at a time until the pain relief. Continue the administration of medication every 3 hours until the pain ceases. The medication should be used for a maximum of 3 days when they should return to the doctor.

Primary Outcome Measures

Name	Time	Method
Visual Analogic Scale, by clinical examination and opinion of the investigator.	3 days

Secondary Outcome Measures

Name	Time	Method
Of adverse events related to study medication by the Naranjo Algorithm.	3 days

Trial Locations

Locations (1)

Faculdade de Medicina do ABC; 🇧🇷 Santo André, São Paulo, Brazil