E02OSMAS0108: 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.

Sponsor

Laboratorios Osorio de Moraes Ltda. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00967317

Collaborator

(none)

188

Enrollment

Location

Arms

Duration (Months)

47.3

Patients Per Site Per Month

Study Details

Study Description

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®.

Condition or Disease	Intervention/Treatment	Phase
Otitis Efficacy Tolerability	Drug: Auris-Sedina Drug: Otosynalar®	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

188 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Dec 1, 2009

Anticipated Primary Completion Date :

Mar 1, 2010

Anticipated Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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.
Active Comparator: 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.	Drug: 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.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Auris-Sedina

Active Comparator: 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.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Visual Analogic Scale, by clinical examination and opinion of the investigator. [3 days]

Secondary Outcome Measures

Of adverse events related to study medication by the Naranjo Algorithm. [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.