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Sponsored by: |
Hoffmann-La Roche |
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Information provided by: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT00412555 |
This study will evaluate the safety of Tamiflu, when used for the prevention of influenza in children during the flu season. Children who would benefit from influenza prophylaxis when influenza is circulating in the community will receive treatment with Tamiflu syrup (or capsules) 30mg-75mg once daily (dependent on body weight) for 6 weeks. Safety data and influenza symptoms will be recorded throughout the study. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Drug: oseltamivir [Tamiflu] |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Multi-Center Trial of Oseltamivir for the Seasonal Prophylaxis of Influenza in Children. |
Enrollment: | 52 |
Study Completion Date: | March 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: oseltamivir [Tamiflu]
30-75mg po daily for 6 weeks
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Ages Eligible for Study: | 1 Year to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
WEST PALM BEACH, Florida, United States, 33409 | |
United States, Pennsylvania | |
PITTSBURGH, Pennsylvania, United States, 15241 | |
United States, Tennessee | |
JACKSON, Tennessee, United States, 38305 | |
United States, Texas | |
EL PASO, Texas, United States, 79925 | |
Canada, British Columbia | |
COQUITLAM, British Columbia, Canada, V3K 3P4 | |
Denmark | |
AALBORG, Denmark, 9000 |
Study Director: | Clinical Trials | Hoffmann-La Roche, +1 973 235 5000 |
Responsible Party: | Hoffmann-La Roche ( Clinical Trials, Study Director ) |
Study ID Numbers: | NV20236 |
Study First Received: | December 15, 2006 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00412555 |
Health Authority: | United States: Food and Drug Administration |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Orthomyxoviridae Infections Oseltamivir |
Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Enzyme Inhibitors Antiviral Agents Pharmacologic Actions |