NCT01610245

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Nitazoxanide and Nitazoxanide Plus Oseltamivir in the Treatment of Acute Uncomplicated Influenza

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,941 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Nitazoxanide
DRUG	Oseltamivir
DRUG	Placebo Oral Tablet
DRUG	Placebo Oral Capsule

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-03-01
• Completion: 2015-04-16
• First posted: 2012-06-01
• Last updated: 2018-03-29

Locations

167 sites across 5 countries: United States, Australia, Belgium, Canada, New Zealand