Trials / Completed
CompletedNCT00644943
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 425 (actual)
- Sponsor
- Abbott · Industry
- Sex
- All
- Age
- 6 Months – 6 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cefdinir (Omnicef) | oral suspension (7 mg/kg, ql2hr) for 5 days |
| DRUG | amoxicillin | oral suspension (45 mg/kg/day, q l2 hours) for 10 days |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2003-04-01
- First posted
- 2008-03-27
- Last updated
- 2008-03-27
Locations
32 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00644943. Inclusion in this directory is not an endorsement.