Trials / Completed
CompletedNCT00645203
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
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
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 447 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 6 Months – 4 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cefdinir | cefdinir oral suspension, 25 mg/kg once daily for 10 days |
Timeline
- Start date
- 2002-07-01
- Primary completion
- 2003-04-01
- First posted
- 2008-03-27
- Last updated
- 2008-03-27
Locations
22 sites across 7 countries: United States, Chile, Costa Rica, Dominican Republic, Guatemala, Israel, Panama
Source: ClinicalTrials.gov record NCT00645203. Inclusion in this directory is not an endorsement.