Status:
UNKNOWN
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.
Lead Sponsor:
Laboratorios Osorio de Moraes Ltda.
Conditions:
Otitis
Efficacy
Eligibility:
All Genders
6+ years
Phase:
PHASE3
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 ass...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2010
Estimated Enrollment :
188 Patients enrolled
Trial Details
Trial ID
NCT00967317
Start Date
December 1 2009
End Date
April 1 2010
Last Update
August 27 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil