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Sponsors and Collaborators: |
Hospital District of Southwestern Finland Hoffmann-La Roche |
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Information provided by: | Hospital District of Southwestern Finland |
ClinicalTrials.gov Identifier: | NCT00593502 |
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.
Condition | Intervention | Phase |
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Influenza |
Drug: oseltamivir Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age |
Estimated Enrollment: | 300 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Oseltamivir
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Drug: oseltamivir
Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days
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2: Placebo Comparator
Placebo
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Drug: placebo
The dosage of placebo will be similar to the active drug
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Ages Eligible for Study: | 1 Year to 3 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Terho J Heikkinen, MD | +358-2-313-2434 | terho.heikkinen@utu.fi |
Finland | |
Turku University Hospital | Recruiting |
Turku, Finland, 20520 | |
Contact: Terho J Heikkinen, MD +358-2-313-2434 terho.heikkinen@utu.fi | |
Principal Investigator: Terho J Heikkinen, MD | |
Sub-Investigator: Heli Silvennoinen, MD | |
Sub-Investigator: Santtu Heinonen, MD | |
Sub-Investigator: Pasi Lehtinen, MD |
Principal Investigator: | Terho J Heikkinen, MD | Turku University Hospital, Turku, Finland |
Responsible Party: | Turku University Hospital, Turku, Finland ( Terho Heikkinen/Consulting Pediatrician, Assistant Professor ) |
Study ID Numbers: | MV21118, EudraCT 2007-004734-17 |
Study First Received: | January 4, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00593502 History of Changes |
Health Authority: | Finland: National Agency for Medicines |
influenza children acute otitis media oseltamivir |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Otitis Otitis Media |
Influenza, Human Orthomyxoviridae Infections Antiviral Agents Oseltamivir |
Anti-Infective Agents RNA Virus Infections Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Orthomyxoviridae Infections Antiviral Agents Pharmacologic Actions |
Oseltamivir Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Therapeutic Uses Influenza, Human |