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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Laboratorios Osorio de Moraes Ltda..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Laboratorios Osorio de Moraes Ltda.
ClinicalTrials.gov Identifier:
NCT00967317
First received: August 25, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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®.


Condition Intervention Phase
Otitis
Efficacy
Tolerability
Drug: Auris-Sedina
Drug: Otosynalar®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Laboratorios Osorio de Moraes Ltda.:

Primary Outcome Measures:
  • Visual Analogic Scale, by clinical examination and opinion of the investigator. [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Of adverse events related to study medication by the Naranjo Algorithm. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 188
Study Start Date: December 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967317

Contacts
Contact: Dagoberto Brandão 55 11 3673 3763 dagoberto@phcbrasil.com.br

Locations
Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Sponsors and Collaborators
Laboratorios Osorio de Moraes Ltda.
Investigators
Principal Investigator: Elie Fiss Faculdade de Medicina do ABC
  More Information

No publications provided

Responsible Party: Maria Angelina Nardy Mattos, Laboratórios Osório de Moraes Ltda.
ClinicalTrials.gov Identifier: NCT00967317     History of Changes
Other Study ID Numbers: E02-OSM-AS-01-08
Study First Received: August 25, 2009
Last Updated: August 25, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Laboratorios Osorio de Moraes Ltda.:
Auris-Sedina
Otitis
Efficacy
Tolerability

Additional relevant MeSH terms:
Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on April 23, 2014