drugset / Trial / NCT00638534
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
Timeline
- Start
- 2004-02
- Primary completion
- 2004-10
- Completion
- 2004-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Telithromycin | Small molecule | 20 mg/kg | — |