Trials / Completed
CompletedNCT00408135
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections
Evaluation of the Safety, Efficacy and Acceptability of HMR 3647 (20％ Fine Granules 1 g Sachet) in Children With Infections
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 111 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 6 Months – 16 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | telithromycin (HMR3647) |
Timeline
- Start date
- 2004-08-01
- Primary completion
- 2005-05-01
- Completion
- 2005-05-01
- First posted
- 2006-12-06
- Last updated
- 2009-04-03
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00408135. Inclusion in this directory is not an endorsement.