Phase III Open Study, Prospective, Multicenter, Randomize... | NCT00967317

Studies
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.

NCT00967317

Sponsor

Laboratorios Osorio de Moraes Ltda.

Status

Unknown status

Last Update Posted

Aug 27, 2009Estimated

Enrollment

188Estimated

Phase

Phase 3

Conditions

Otitis
Efficacy
Tolerability

Interventions

Auris-Sedina
Otosynalar®

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Mar 2010Estimated

Completion Date

Apr 2010Estimated

First Submitted Date

Aug 25, 2009

First Submission Date that Met QC Criteria

Aug 25, 2009

First Posted Date

Aug 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2009

Last Update Posted Date

Aug 27, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

188Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	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.	Drug: Otosynalar®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Auris-Sedina	Drug	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.

Measure	Description	Time Frame
Visual Analogic Scale, by clinical examination and opinion of the investigator.		3 days

Measure	Description	Time Frame
Of adverse events related to study medication by the Naranjo Algorithm.		3 days

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases