Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00645203 | Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media | PHASE2 | COMPLETED | 447 | — | — | Jul 1, 2002 | - | Mar 27, 2008 | 22 | United States, Chile +5 |
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| cefdinir | DRUG | cefdinir oral suspension, 25 mg/kg once daily for 10 days |
Inclusion Criteria: * Male and female children between 6 months and 4 years of age * Weight does not exceed 40 kg * Clinical diagnosis is acute otitis media * Have evidence of middle ear fluid * At risk for persistent or recurrent otitis media * Generally in good health Exclusion Criteria: * Sens...