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Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

NCT00593502 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 409

Last updated 2009-06-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

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

DRUG

placebo

The dosage of placebo will be similar to the active drug

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Hospital District of Southwestern Finland

    lead OTHER

Principal Investigators

  • Terho J Heikkinen, MD · Turku University Hospital, Turku, Finland

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593502 on ClinicalTrials.gov