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

NCT03336619 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1030

Last updated 2022-06-28

Study results available
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Summary

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

Conditions

Interventions

DRUG

Nitazoxanide

Nitazoxanide 600 mg administered orally twice daily for five days

DRUG

Placebo

Placebo administered orally twice daily for five 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
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2019-04-17
Completion
2019-04-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Puerto Rico

Study Locations

More Related Trials

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 NCT03336619 on ClinicalTrials.gov