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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 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 1,500 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315003
The ClinicalTrials.gov registry entry for NCT00315003 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.
NCT00315003 reports 0 study locations.
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.
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