OtitisPhase 3E02OSMAS0108NCT00967317
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.
A Phase 3 study testing Auris-Sedina and Otosynalar® in people with Otitis and Efficacy, run by Laboratorios Osorio de Moraes Ltda. at 1 site in Brazil.
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®. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Otitis, Efficacy, Tolerability
- What is being tested?
- Auris-Sedina and Otosynalar®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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®.
Read the 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.
- Conditions
- Otitis, Efficacy, Tolerability
- Being tested
- Auris-Sedina, Otosynalar®
- Keywords
- Auris-Sedina, Otitis, Efficacy, Tolerability
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auris-SedinaDrug
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®Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Auris-Sedina | Experimental | 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. Receives: Drug: Auris-Sedina |
| Otosynalar® | Active comparator | 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. Receives: Drug: Otosynalar® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogic Scale, by clinical examination and opinion of the investigator.
Measured: 3 days
Secondary outcomes (1)
Of adverse events related to study medication by the Naranjo Algorithm.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Osorio de Moraes Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elie Fiss, Principal investigator, Faculdade de Medicina do ABC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967317
- Sponsor's protocol ID
- E02-OSM-AS-01-08
- Acronym
- E02OSMAS0108
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2009
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00967317
- Acronym / sponsor ID
- E02OSMAS0108 / E02-OSM-AS-01-08
- Conditions
- Otitis, Efficacy, Tolerability
- Keywords
- Auris-Sedina, Otitis, Efficacy, Tolerability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Laboratorios Osorio de Moraes Ltda.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auris-Sedina | Experimental | Drug: Auris-SedinaDrip 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 comparator | 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. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auris-SedinaDrip 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 |
| 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® |
Primary outcome
Visual Analogic Scale, by clinical examination and opinion of the investigator.
Time frame: 3 days
1 secondary outcome
Of adverse events related to study medication by the Naranjo Algorithm.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
Related trials for Otitis
Recruiting
RSV Burden in Outpatient and Hospital Settings
RSV Infection, Children, Only
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Active, not recruiting
Dynamic Change and Immune Response to Nasopharyngeal Carriage and Acute Otitis Media Pathogens
Acute Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elie Fiss principal investigator
Faculdade de Medicina do ABC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Auris-Sedina and Otosynalar® in people with Otitis and Efficacy, run by Laboratorios Osorio de Moraes Ltda. at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dagoberto Brandão (55 11 3673 3763, dagoberto@phcbrasil.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogic Scale, by clinical examination and opinion of the investigator. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2009.