Phase III Open Study, Prospective, Multicenter, Randomized, Comparative to the Positive Control f… (NCT00967317) | Clinical Trial Compass
UnknownPhase 3
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.
Brazil188 participantsStarted 2009-12
Plain-language 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®.
Who can participate
Age range6 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Visual Analogic Scale, by clinical examination and opinion of the investigator.