Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-27 @ 3:10 AM
Study NCT ID:
NCT00645203
Status:
COMPLETED
Last Update Posted:
2008-03-27
First Post:
2008-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
Sponsor:
Abbott
Organization:
Study Overview
Official Title:
An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects With Acute Otitis Media
Status:
COMPLETED
Status Verified Date:
2008-03
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:
To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
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?: