Clinical trial
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given…
NCT00174811 · Sanofi, Industry · Terminated
Key facts
| NCT number | NCT00174811 |
|---|---|
| Title | Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections |
| Official title | Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of Telithromycin 25 mg/kg Given Once Daily for 5 or 10 Days Depending on Age and Previous Treatment History Versus Cefuroxime Axetil 15 mg/kg, Given Twice Daily for 10 Days, in Children With… |
| Lead sponsor | Sanofi, Industry |
| Status | Terminated |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Otitis Media |
| Intervention type | Drug |
| Interventions | telithromycin (HMR3647) |
| Enrollment | 639 |
| Start date | Jun 1, 2005 |
| Primary completion | Jun 1, 2006 |
| Completion | Jun 1, 2006 |
| First posted | Sep 15, 2005 |
| Last update posted | Apr 3, 2009 |
| Countries | France, United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: