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.
NCT ID: NCT00967317
Last Updated: 2009-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
188 participants
INTERVENTIONAL
2009-12-31
2010-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
ALL
No
Sponsors
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Laboratorios Osorio de Moraes Ltda.
INDUSTRY
Responsible Party
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Laboratórios Osório de Moraes Ltda.
Principal Investigators
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Elie Fiss
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina do ABC
Locations
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Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Countries
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Central Contacts
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Other Identifiers
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E02-OSM-AS-01-08
Identifier Type: -
Identifier Source: org_study_id