Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00967317
Status:
UNKNOWN
Last Update Posted:
2009-08-27
First Post:
2009-08-25
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
Sponsor:
Laboratorios Osorio de Moraes Ltda
Organization:
Laboratorios Osorio de Moraes Ltda
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
E02OSMAS0108
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None