drugset / Trial / NCT01610245

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

NCT01610245

Phase 3 Completed 1941 enrolled Romark Laboratories L.C.
RandomizedParallel-groupTriple-blindTreatment

Summary

This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.

Timeline

Start
2013-03
Primary completion
2015-03
Completion
2015-04-16

Drugs

EvaluationDrugModalityDoseRoute
Comparator Nitazoxanide Other / unclassified 600 mg Oral
Comparator Oseltamivir Small molecule 75 mg Oral

Indications