CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 624 enrolled
Drug / intervention
Nitazoxanide +2 moredrug
Likely dose
Nitazoxanide 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01227421
NCT01227421Phase 3Completed

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

Romark Laboratories L.C.·interventional·Posted Oct 25, 2010·Updated Oct 12, 2023

In Brief

A Phase 3 clinical trial evaluating Nitazoxanide and Placebo for Influenza. Completed, enrolled 624 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2010
Enrollment StartDec 1, 2010
Primary CompletionApr 1, 2011
Study CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.7 years ago

Interventions

Nitazoxanidedrug

Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days

Nitazoxanidedrug

Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days

Placebodrug

Tablets, (2 tablets) twice daily with food for 5 days