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
1 other identifier
interventional
188
1 country
1
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®.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2009
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 27, 2009
CompletedStudy Start
First participant enrolled
December 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedAugust 27, 2009
August 1, 2009
3 months
August 25, 2009
August 25, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analogic Scale, by clinical examination and opinion of the investigator.
3 days
Secondary Outcomes (1)
Of adverse events related to study medication by the Naranjo Algorithm.
3 days
Study Arms (2)
Auris-Sedina
EXPERIMENTALDrip 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®
ACTIVE COMPARATORDrip 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elie Fiss
Faculdade de Medicina do ABC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 27, 2009
Study Start
December 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
August 27, 2009
Record last verified: 2009-08