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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: Clinical Trial Phase 3 study, sponsored by Sanofi.
NCT00315042 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 314 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
Why NCT00315042 stopped before completion
NCT00315042 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Penicillin is the first listed.
NCT00315042 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00315042's enrollment target sits among peer trials
314 1096th of 2000 higher than 900 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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