Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000363
Status:
COMPLETED
Last Update Posted:
2006-04-24
First Post:
1999-11-02
Brief Title:
Acute Otitis Media Adjuvant Therapy to Improve Outcome
Sponsor:
National Institute on Deafness and Other Communication Disorders NIDCD
Organization:
National Institute on Deafness and Other Communication Disorders NIDCD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
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:
None
Brief Summary:
Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children Despite the availability of effective antibiotic therapy for otitis media treatment failures persistent effusions and recurrences are common This Phase III outpatient study aims to test whether adjuvant therapy an antihistamine or a corticosteroid in addition to antibiotic therapy improves the acute and long-term outcomes of patients with acute otitis media This study is targeted to recruiting 200 infants age less than one year patient and parent participation is estimated to continue for one year after enrollment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DC002620-04 | NIH | None | httpsreporternihgovquickSearchR01DC002620-04 |