Clinical trial NCT00967317: 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.
Official title: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Otitis
Efficacy
Tolerability
Keywords: Auris-Sedina
Otitis
Efficacy
Tolerability
Lead sponsor: Laboratorios Osorio de Moraes Ltda.
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogic Scale, by clinical examination and opinion of the investigator.
timeFrame: 3 days
Secondary outcomes:
measure: Of adverse events related to study medication by the Naranjo Algorithm.
timeFrame: 3 days
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: Faculdade de Medicina do ABC
name: Elie Fiss
role: PRINCIPAL_INVESTIGATOR
References: