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NCT00315042 · ClinicalTrials.gov registry record · Phase 3
TELI TON - Telithromycin in Tonsillitis
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 314
- Enrollment target
NCT00315042 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 314 participants.
The verdict
NCT00315042, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 314 participants
- Enrollment target
Study Summary
This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to \< 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily for 5 days or penicillin V, 13.3 mg/kg three times daily for 10 days. Matching placebo for telithromycin and penicillin V will also be dispensed for 5 and 10 days respectively, to provide blinding to the different treatment regimens. A positive rapid identification test for streptococcal Group A antigen will be required for all subjects at Visit 1 (Day 1) for entry into the study. Throat swab specimens for bacterial culture, identification, and antibiotic-susceptibility testing will be taken at Visits 1, 3 and 4.
Interventions
- DRUG Penicillin
- DRUG Telithromycin (HMR3647)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2006-03 |
| Est. Completion | 2006-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315042
The ClinicalTrials.gov registry entry for NCT00315042 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 314 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 Penicillin is the first listed.
NCT00315042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315042 about?
NCT00315042 is a clinical study titled "TELI TON - Telithromycin in Tonsillitis". This is a multinational, randomized (1:1), double blind, double dummy, comparator-controlled, 2 parallel treatment group study in subjects from 6 months to \< 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P).Each subject will receive either telithromycin 25 mg/kg once daily...
What is the current status of trial NCT00315042?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 314 participants. The study started on 2006-03. Estimated completion is 2006-08.
What interventions are being tested in trial NCT00315042?
The interventions under investigation include: Penicillin (DRUG), Telithromycin (HMR3647) (DRUG).
Who is sponsoring clinical trial NCT00315042?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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