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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00315003 |
This is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and <72 months [< 6 years of age]) with AOM.Subjects will be randomized to receive either telithromycin (50 mg/mL) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/mL) oral suspension (10 mg/kg once on Day 1, followed by 5 mg/kg once daily on Days 2-5, not to exceed 500 mg onDay 1 and 250 mg/day from Days 2 - 5. Matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.Assessments and reporting of safety will be carried out at all visits.
Condition | Intervention | Phase |
---|---|---|
Otitis Media, Suppurative Otitis Media, Purulent |
Drug: Telithromycin Drug: Azithromycin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Multinational, Randomized, Double-Blind, Double-Dummy, Comparative Study to Evaluate the Efficacy and Safety of 5 Days Telithromycin 25mg/kg od Versus 5 Days Azithromycin 10 mg/kg od Followed by 5 mg/kg od for 4 Days, in Children With Acute Otitis Media |
Estimated Enrollment: | 1500 |
Study Start Date: | January 2006 |
Study Completion Date: | July 2006 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Months to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for enrollment into the study:
Tympanometry exhibiting:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
United States, New Jersey | |
Sanofi-Aventis | |
Bridgewater, New Jersey, United States, 08807 | |
Argentina | |
Sanofi-Aventis | |
Buenos Aires, Argentina, 1642 | |
Brazil | |
Sanofi-Aventis | |
Sao Paulo, Brazil, 05677-000 | |
Canada | |
Sanofi-Aventis | |
Laval, Canada | |
Chile, Santiago | |
Sanofi-Aventis | |
Providencia, Santiago, Chile | |
Colombia | |
Sanofi-Aventis | |
Santafe de Bogota, Colombia | |
Costa Rica | |
Sanofi-Aventis | |
San José, Costa Rica | |
Czech Republic | |
Sanofi-Aventis | |
Praha, Czech Republic, 160 00 | |
Dominican Republic | |
Sanofi-Aventis | |
Santo-Domingo, Dominican Republic | |
Guatemala | |
Sanofi-Aventis | |
Guatemala, Guatemala | |
Israel | |
Sanofi-Aventis | |
Israel, Israel | |
Panama | |
Sanofi-Aventis | |
Panama, Panama | |
Peru | |
Sanofi-Aventis | |
Lima, Peru |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC6132, HMR3647B/3002 |
Study First Received: | April 13, 2006 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00315003 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Ethics Review Committee; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Chile: Instituto de Salud Publica de Chile; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs |
Otitis Media Suppurative Purulent Ketolide |
Azithromycin Telithromycin Controlled Clinical Trials |
Anti-Bacterial Agents Otorhinolaryngologic Diseases Azithromycin Otitis Otitis Media |
Suppuration Otitis Media, Suppurative Ear Diseases Telithromycin Inflammation |
Anti-Infective Agents Otorhinolaryngologic Diseases Otitis Media Otitis Media, Suppurative Infection Ear Diseases Pharmacologic Actions Telithromycin |
Inflammation Anti-Bacterial Agents Pathologic Processes Therapeutic Uses Otitis Azithromycin Suppuration |