Trials / Completed
CompletedNCT00638534
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 56 (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 (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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Telithromycin (HMR3647) |
Timeline
- Start date
- 2004-02-01
- Primary completion
- 2004-10-01
- Completion
- 2004-10-01
- First posted
- 2008-03-19
- Last updated
- 2009-10-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00638534. Inclusion in this directory is not an endorsement.