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NCT00315549 · ClinicalTrials.gov registry record · Phase 3
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 233
- Enrollment target
NCT00315549 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 233 participants.
The verdict
NCT00315549, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 233 participants
- Enrollment target
Study Summary
This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, 800 mg once daily for 5 days or penicillin V 250 mg over-encapsulated tablets, 500 mg three times daily for 10days. Matching placebo capsules will be dispensed to maintain the blind between the treatment groups.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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 233 participants |
| Start Date | 2006-02 |
| Est. Completion | 2006-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00315549
The ClinicalTrials.gov registry entry for NCT00315549 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 233 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.
NCT00315549 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00315549 about?
NCT00315549 is a clinical study titled "TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults". This is a multinational, randomized (1:1), double blind, comparator-controlled, 2 parallel treatment group study in subjects equal to or over 13 years of age, with Streptococcus pyogenes tonsillitis/pharyngitis (T/P). Each subject will receive either telithromycin, 400 mg over-encapsulated tablets, ...
What is the current status of trial NCT00315549?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 233 participants. The study started on 2006-02. Estimated completion is 2006-09.
What interventions are being tested in trial NCT00315549?
The interventions under investigation include: Penicillin (DRUG), Telithromycin (DRUG).
Who is sponsoring clinical trial NCT00315549?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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