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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00315549 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tonsillitis Pharyngitis |
Drug: Telithromycin Drug: Penicillin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| 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 Tonsillitis/Pharyngitis |
| Enrollment: | 233 |
| Study Start Date: | February 2006 |
| Study Completion Date: | September 2006 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age equal to or over 13 years;
Subject is premenarchal or surgically incapable of bearing children,
Have normal menstrual flow within 1 month before study entry,
Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on:
A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs:
Exclusion Criteria:
Contacts and Locations| United States, New Jersey | |
| Sanofi-aventis | |
| Bridgewater, New Jersey, United States, 08807 | |
| Argentina, Buenos Aires | |
| Sanofi-aventis | |
| San Isidro, Buenos Aires, Argentina, 1642 | |
| Chile, Santiago | |
| Sanofi-aventis | |
| Providencia, Santiago, Chile | |
| Costa Rica | |
| Sanofi-aventis | |
| San Jose, Costa Rica | |
| Study Director: | ICD CSD | Sanofi-Aventis |
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC6134, HMR3647B/3006 |
| Study First Received: | April 14, 2006 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00315549 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Chile: Instituto de Salud Publica de Chile; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
|
Tonsillitis pharyngitis penicillin |
telithromycin ketolides clinical trials |
|
Anti-Infective Agents Anti-Bacterial Agents Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses |
Tonsillitis Stomatognathic Diseases Pharyngitis Pharyngeal Diseases Pharmacologic Actions Telithromycin |