Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)|
- Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
- Clinical efficacy: tympanic signs
- Acceptability: compliance and willingness to take medication
- Pharmacokinetics: plasma concentrations of telithromycin
|Study Start Date:||February 2004|
|Study Completion Date:||October 2004|
|Primary Completion Date:||October 2004 (Final data collection date for primary outcome measure)|