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

NCT01227421 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2023-10-12

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Romark Laboratories L.C.

    lead INDUSTRY

Principal Investigators

  • Jean-Francois Rossignol, M.D., Ph.D. · Romark Laboratories L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-04-30
Completion
2011-05-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01227421 on ClinicalTrials.gov