Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
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|ClinicalTrials.gov Identifier: NCT00408135|
Recruitment Status : Completed
First Posted : December 6, 2006
Last Update Posted : April 3, 2009
The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).
Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.
|Condition or disease||Intervention/treatment||Phase|
|Infections Child||Drug: telithromycin (HMR3647)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections|
|Study Start Date :||August 2004|
|Actual Primary Completion Date :||May 2005|
|Actual Study Completion Date :||May 2005|
- Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).
- Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit
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): NCT00408135
|Study Director:||Norifumi Yamamoto||sanofi-aventis Japan|