drugset / Trial / NCT01227421

Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza

NCT01227421

Phase 2/3 Completed 624 enrolled Romark Laboratories L.C.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.

Timeline

Start
2010-12
Primary completion
2011-04
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitazoxanide Other / unclassified 300 mg Oral
Comparator Nitazoxanide Other / unclassified 600 mg Oral

Indications