Clinical Trial: Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Labe
Brief 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.
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Clinical efficacy: tympanic signs
- Acceptability: compliance and willingness to take medication
- Pharmacokinetics: plasma concentrations of telithromycin
Original Secondary Outcome: Same as current
Information By: Sanofi
Dates:
Date Received: March 12, 2008
Date Started: February 2004
Date Completion:
Last Updated: October 1, 2009
Last Verified: October 2009
