NCT03336619

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,030 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Detailed description

A multicenter, randomized, double-blind, placebo controlled trial to evaluate efficacy and safety of nitazoxanide (NTZ) in the treatment of uncomplicated influenza.

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Nitazoxanide 600 mg administered orally twice daily for five days
DRUG	Placebo	Placebo administered orally twice daily for five days

Timeline

• Start date: 2018-01-17
• Primary completion: 2019-04-17
• Completion: 2019-04-17
• First posted: 2017-11-08
• Last updated: 2022-06-28
• Results posted: 2022-06-28

Locations

38 sites across 3 countries: United States, Australia, Puerto Rico

Regulatory

• FDA-regulated drug study