NCT01227421

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

A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents With Acute Uncomplicated Influenza

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 624 (actual)
• Sponsor: Romark Laboratories L.C. · Industry
• Sex: All
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the time to resolution of all clinical symptoms of influenza. The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events and laboratory safety tests. Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of patients).

Conditions

• Influenza

Interventions

Type	Name	Description
DRUG	Nitazoxanide	Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days
DRUG	Nitazoxanide	Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days
DRUG	Placebo	Tablets, (2 tablets) twice daily with food for 5 days

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2010-10-25
• Last updated: 2023-10-12
• Results posted: 2014-01-08

Locations

1 site across 1 country: United States