Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
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|ClinicalTrials.gov Identifier: NCT00638534|
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : October 2, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Otitis Media||Drug: Telithromycin (HMR3647)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||October 2004|
|Actual Study Completion Date :||October 2004|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638534