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)
Recruitment status was Not yet recruiting
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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. |
- Visual Analogic Scale, by clinical examination and opinion of the investigator. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Dagoberto Brandão | 55 11 3673 3763 | dagoberto@phcbrasil.com.br |
| Brazil | |
| Faculdade de Medicina do ABC | |
| Santo André, São Paulo, Brazil | |
| 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 May 22, 2013