Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00315549
Status:
TERMINATED
Last Update Posted:
2009-04-03
First Post:
2006-04-14
Brief Title:
TELI TAD - Telithromycin in Tonsillitis in Adolescents and Adults
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Multinational Randomized Double Blind Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 800 mg od Versus 10 Days Penicillin V 500 mg Tid in Adolescent and Adult Subjects Equal to or Over 13 Years With Streptococcus Pyogenes TonsillitisPharyngitis
Status:
TERMINATED
Status Verified Date:
2009-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Pediatric development program terminated by sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multinational randomized 11 double blind comparator-controlled 2 parallel treatment group study in subjects equal to or over 13 years of age with Streptococcus pyogenes tonsillitispharyngitis TP 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 groupsA 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HMR3647B3006 | None | None | None |