Trial | NCT00967317  Report issue

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    188
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®.
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.
Study Started
Dec 31
2009
Primary Completion
Mar 31
2010
Anticipated
Study Completion
Apr 30
2010
Anticipated
Last Update
Aug 27
2009
Estimate

Drug 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.

Drug 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.

Auris-Sedina Experimental

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® Active Comparator

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.

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.
No Results Posted