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NCT00315003 · ClinicalTrials.gov registry record · Phase 3
TELI COM - Telithromycin in Children With Otitis Media
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,500
- Enrollment target
NCT00315003: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT00315003 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 1,500 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00315003, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,500 participants
- Enrollment target
Study Summary
This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.
Interventions
- DRUG Azithromycin
- DRUG Telithromycin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,500 participants |
| Start Date | 2006-01 |
| Est. Completion | 2006-07 |
| Phase | Phase 3 |
Why NCT00315003 stopped before completion
NCT00315003 is an interventional study that assigns participants to a tested intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% higher).
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT00315003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00315003 about?
NCT00315003 is a clinical study titled "TELI COM - Telithromycin in Children With Otitis Media". This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for ...
What is the current status of trial NCT00315003?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,500 participants. The study started on 2006-01. Estimated completion is 2006-07.
What interventions are being tested in trial NCT00315003?
The interventions under investigation include: Azithromycin (DRUG), Telithromycin (DRUG).
Who is sponsoring clinical trial NCT00315003?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315003's enrollment target sits among peer trials
1,500 158th of 2000 higher than 1,838 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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