Efficacy, Otitis, Tolerability
Conditions
Keywords
Auris-Sedina, Otitis, Efficacy, Tolerability
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.
Interventions
DRUGAuris-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.
DRUGOtosynalar®
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.
Sponsors
Laboratorios Osorio de Moraes Ltda.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogic Scale, by clinical examination and opinion of the investigator. | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Of adverse events related to study medication by the Naranjo Algorithm. | 3 days |
Countries
Brazil
Contacts
Primary ContactDagoberto Brandão
Outcome results
None listed