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.

Efficacy Clinical Trial

— E02OSMAS0108  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00967317
• Other study ID #: E02-OSM-AS-01-08
• Status: Not yet recruiting
• Phase: Phase 3
• First received: August 25, 2009
• Last updated: August 25, 2009
• Start date: December 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2009
• Source: Laboratorios Osorio de Moraes Ltda.
• Contact: Dagoberto Brandão
• Phone: 55 11 3673 3763
• Email: dagoberto[@]phcbrasil.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 188
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Efficacy
• Otitis
• Otitis Externa
• Tolerability

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Laboratorios Osorio de Moraes Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogic Scale, by clinical examination and opinion of the investigator.		3 days	No
Secondary	Of adverse events related to study medication by the Naranjo Algorithm.		3 days	Yes