drugset / Trial / NCT00949533

A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

NCT00949533

Phase 3 Completed 37 enrolled Hoffmann-La Roche
RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (\</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams \[mg\] orally twice daily \[bid\]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (\>) 100.

Timeline

Start
2009-08
Primary completion
2010-10
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Oseltamivir Small molecule 30 mg Oral
Subject Oseltamivir Small molecule 60 mg Oral
Subject Oseltamivir Small molecule 75 mg Oral
Subject Oseltamivir Small molecule 150 mg Oral

Indications