search
Back to results

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)

Primary Purpose

Otitis, Efficacy, Tolerability

Status
Unknown status
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Auris-Sedina
Otosynalar®
Sponsored by
Laboratorios Osorio de Moraes Ltda.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis focused on measuring Auris-Sedina, Otitis, Efficacy, Tolerability

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculdade de Medicina do ABC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Auris-Sedina

Otosynalar®

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual Analogic Scale, by clinical examination and opinion of the investigator.

Secondary Outcome Measures

Of adverse events related to study medication by the Naranjo Algorithm.

Full Information

First Posted
August 25, 2009
Last Updated
August 25, 2009
Sponsor
Laboratorios Osorio de Moraes Ltda.
search

1. Study Identification

Unique Protocol Identification Number
NCT00967317
Brief 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.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Laboratorios Osorio de Moraes Ltda.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis, Efficacy, Tolerability
Keywords
Auris-Sedina, Otitis, Efficacy, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Auris-Sedina
Arm Type
Experimental
Arm Description
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.
Arm Title
Otosynalar®
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Auris-Sedina
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Otosynalar®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogic Scale, by clinical examination and opinion of the investigator.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Of adverse events related to study medication by the Naranjo Algorithm.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dagoberto Brandão
Phone
55 11 3673 3763
Email
dagoberto@phcbrasil.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elie Fiss
Organizational Affiliation
Faculdade de Medicina do ABC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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.

We'll reach out to this number within 24 hrs