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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01610245

Public ClinicalTrials.gov record NCT01610245. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 10:15 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study is a global multicenter randomized factorial double-blind, placebo-controlled trial designed to evaluate (i) efficacy and safety of nitazoxanide 600 mg administered orally twice daily for five days compared to a placebo in the treatment of acute uncomplicated influenza and (ii) efficacy and safety of combination therapy with nitazoxanide 600 mg plus Oseltamivir 75 mg co-administered orally twice daily for five days compared to nitazoxanide monotherapy (600 mg b.i.d. for 5 days) and Oseltamivir monotherapy (75 mg b.i.d. for 5 days) in the treatment of acute uncomplicated influenza.

Study identification

NCT ID
NCT01610245
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Romark Laboratories L.C.
Industry
Enrollment
1,941 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2013
Primary completion
Feb 28, 2015
Completion
Apr 15, 2015
Last update posted
Mar 28, 2018

2013 – 2015

United States locations

U.S. sites
136
U.S. states
35
U.S. cities
124
Facility City State ZIP Site status
Influence Study Site Birmingham Alabama 35209
Influence Study Site Dothan Alabama 36305
Influence Study Site Hoover Alabama 35216
Influence Study Site Mobile Alabama 36608
Influence Study Site Mesa Arizona 85206
Influence Study Site Mesa Arizona 85213
Influence Study Site Tucson Arizona 85741
Influence Study Site Hot Springs Arkansas 71913
Influence Study Site Jonesboro Arkansas 72401
Influence Study Site Anaheim California 92805
Influence Study Site Fresno California 93726
Influence Study Site Garden Grove California 92844
Influence Study Site Harbor City California 90710
Influence Study Site Huntington Beach California 92647
Influence Study Site Lomita California 90719
Influence Study Site Long Beach California 98013
Influence Study Site Modesto California 95350
Influence Study Site Norco California 92860
Influence Study Site San Ramon California 94582
Influence Study Site Stockton California 95204
Influence Study Site Centennial Colorado 80112
Influence Study Site Colorado Springs Colorado 80906
Influence Study Site Colorado Springs Colorado 80920
Influence Study Site Littleton Colorado 80128
Influence Study Site Longmont Colorado 80501
Influence Study Site Thornton Colorado 80233
Influence Study Site Boynton Beach Florida 33472
Influence Study Site Coral Gables Florida 33134
Influence Study Site Edgewater Florida 32132
Influence Study Site Kissimmee Florida 34741
Influence Study Site Lauderdale Lakes Florida 33319
Influence Study Site Miami Florida 33174
Influence Study Site Orlando Florida 32806
Influence Study Site Pembroke Pines Florida 33028
Influence Study Site Saint Cloud Florida 34769
Influence Study Site West Palm Beach Florida 33406
Influence Study Site Atlanta Georgia 30312
Influence Study Site Canton Georgia 30114
Influence Study Site Columbus Georgia 31904
Influence Study Site Blackfoot Idaho 83221
Influence Study Site Skokie Illinois 60077
Influence Study Site Evansville Indiana 47725
Influence Study Site Franklin Indiana 46131
Influence Study Site Muncie Indiana 47301
Influence Study Site Augusta Kansas 67010
Influence Study Site Kansas City Kansas 64133
Influence Study Site Newton Kansas 67114
Influence Study Site Wichita Kansas 67205
Influence Study Site Wichita Kansas 67207
Influence Study Site Hawesville Kentucky 42348
Influence Study Site Madisonville Kentucky 42431
Influence Study Site Owensboro Kentucky 42303
Influence Study Site Eunice Louisiana 70535
Influence Study Site Lafayette Louisiana 70503
Influence Study Site Lake Charles Louisiana 70601
Influence Study Site Fall River Massachusetts 02720
Influence Study Site Ann Arbor Michigan 48105
Influence Study Site Chelsea Michigan 48118
Influence Study Site Essexville Michigan 48732
Influence Study Site Niles Michigan 49120
Influence Study Site Troy Michigan 48098
Influence Study Site Bridgeton Missouri 63044
Influence Study Site Fremont Nebraska 68025
Influence Study Site Las Vegas Nevada 89102
Influence Study Site Las Vegas Nevada 89128
Influence Study Site Teaneck New Jersey 07666
Influence Study Site Albuquerque New Mexico 87102
Influence Study Site Brooklyn New York 11203
Influence Study Site Brooklyn New York 11206
Influence Study Site Great Neck New York 11023
Influence Study Site New York New York 10016
Influence Study Site Rochester New York 14642
Influence Study Site Westfield New York 14787
Influence Study Site Charlotte North Carolina 25205
Influence Study Site Charlotte North Carolina 28209
Influence Study Site Hickory North Carolina 28602
Influence Study Site Mooresville North Carolina 28117
Influence Study Site Winston-Salem North Carolina 27103
Influence Study Site Columbus Ohio 43214
Influence Study Site Dayton Ohio 45432
Influence Study Site Groveport Ohio 43125
Influence Study Site Lyndhurst Ohio 44124
Influence Study Site Middleburg Heights Ohio 44130
Influence Study Site Milford Ohio 45150
Influence Study Site Willoughby Hills Ohio 44094
Influence Study Site Wooster Ohio 44691
Influence Study Site Tulsa Oklahoma 74136
Influence Study Site Ashland Oregon 97520
Influence Study Site Gresham Oregon 97030
Influence Study Site Altoona Pennsylvania 16602
Influence Study Site Lansdale Pennsylvania 19446
Influence Study Site Pittsburgh Pennsylvania 15212
Influence Study Site Pittsburgh Pennsylvania 15236
Influence Study Site Reading Pennsylvania 19606
Influence Study Site Scottdale Pennsylvania 15683
Influence Study Site Uniontown Pennsylvania 15401
Influence Study Site Warwick Rhode Island 02886
Influence Study Site Charleston South Carolina 29412
Influence Study Site Rapid City South Dakota 57701
Influence Study Site Rapid City South Dakota 57702
Influence Study Site Bristol Tennessee 37620
Influence Study Site Columbia Tennessee 38401
Influence Study Site Elizabethton Tennessee 37643
Influence Study Site Franklin Tennessee 37067
Influence Study Site Jackson Tennessee 38305
Influence Study Site Smyrna Tennessee 37167
Influence Study Site Austin Texas 78758
Influence Study Site Beaumont Texas 77701
Influence Study Site Bryan Texas 77802
Influence Study Site Houston Texas 77055
Influence Study Site Houston Texas 77062
Influence Study Site Irving Texas 75039
Influence Study Site Lake Jackson Texas 77566
Influence Study Site North Richland Hills Texas 76180
Influence Study Site Pharr Texas 78577
Influence Study Site Plano Texas 75024
Influence Study Site San Antonio Texas 77566
Influence Study Site San Antonio Texas 78207
Influence Study Site San Antonio Texas 78258
Influence Study Site Sugar Land Texas 77479
Influence Study Site Waco Texas 76712
Influence Study Site Draper Utah 84020
Influence Study Site Magna Utah 84044
Influence Study Site Orem Utah 84058
Influence Study Site Salt Lake City Utah 84117
Influence Study Site Alexandria Virginia 22304
Influence Study Site Ashburn Virginia 20147
Influence Study Site Charlottesville Virginia 22908
Influence Study Site Gainesville Virginia 20155
Influence Study Site Midlothian Virginia 23114
Influence Study Site Norfolk Virginia 23507
Influence Study Site Virginia Beach Virginia 23455
Influence Study Site Port Orchard Washington 98366
Influence Study Site Spokane Washington 99202
Influence Study Site Spokane Washington 99218
Influence Study Site La Crosse Wisconsin 54601

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01610245, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 28, 2018 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01610245 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →