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. (E02OSMAS0108)

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®.

Study Overview

• Status: Unknown
• Conditions: Otitis; Efficacy; Tolerability
• Intervention / Treatment: Drug: Auris-Sedina; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Santo André, São Paulo, Brazil
      • Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Visual Analogic Scale, by clinical examination and opinion of the investigator.	3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Of adverse events related to study medication by the Naranjo Algorithm.	3 days

Collaborators and Investigators

• Sponsor: Laboratorios Osorio de Moraes Ltda.
• Investigators: Principal Investigator: Elie Fiss, Faculdade de Medicina do ABC

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 27, 2009

Study Record Updates

• Last Update Posted (Estimate): August 27, 2009
• Last Update Submitted That Met QC Criteria: August 25, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: Efficacy; Tolerability; Auris-Sedina; Otitis
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis Externa; Otitis
• Other Study ID Numbers: E02-OSM-AS-01-08