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 Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Otitis, Efficacy, Tolerability

Intervention / Treatment
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* Drug: Auris-Sedina
* Drug: Otosynalar®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auris-Sedina<br>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<br>* 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.<br>|
| Active Comparator: Otosynalar®<br>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®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale, by clinical examination and opinion of the investigator. |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Of adverse events related to study medication by the Naranjo Algorithm. |  | 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Auris-Sedina, Otitis, Efficacy, Tolerability