Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
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 Oct 17, 2026, 2:16 AM 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
Mar 2013 (Type not available)
Primary completion
Mar 2015 (Actual)
Completion
Apr 16, 2015 (Actual)
Last update posted
Mar 29, 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 29, 2018 · Synced Oct 17, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01610245 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →