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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Laboratorios Osorio de Moraes Ltda. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Otitis
• Efficacy
• Tolerability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-08-27
• Last updated: 2009-08-27

Locations

1 site across 1 country: Brazil