At a glance
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A Phase II, Multicenter, Randomized, Double-Mask, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects With Uncomplicated Acute Influenza.
In Brief
A Phase 2 clinical trial evaluating Peramivir 150 mg, Peramivir 300 mg, and 1 other intervention for Influenza. Completed, enrolled 344 participants across 69 sites in 2 countries.
Detailed Summary
This is a study for patients with flu who also have a fever as well as other flu symptoms. Patients must have had symptoms for less than 48 hours in order to participate. Patients will have two out of three chances of getting an active study treatment and the other third will receive a placebo (dummy drug). Nobody will know who gets the active drug and who gets the inactive drug. All patients will get supplies to treat symptoms of flu. Patients will need to be seen 5 more times after they are enrolled in the study.
Study Details
Timeline
Interventions
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).