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InfluenzaPhase 3NCT01610245

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

A Phase 3 study testing Nitazoxanide and Oseltamivir in people with Influenza, run by Romark Laboratories L.C. at 167 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 13 to 65 years
Conditions the study is for
Influenza
What is being tested?
Nitazoxanide and Oseltamivir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,941 participants
Where
167 sitesin 5 countries
Study dates
Mar 2013to 16 Apr 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 13 to 65 years
  • Presence of clinical signs and/or symptoms consistent with acute illness compatible with influenza infection (each of the following is required):
  • oral temperature of ≥100.4 °F or ≥38 °C (obtained in office or self-measured within 12 hours prior to screening - if self-measured, subject must also have taken an antipyretic within 4 hours prior to screening) AND
  • at least one of the following respiratory symptoms (cough, sore throat, nasal obstruction) that is considered by the patient to be moderate or severe (greater than mild severity) AND
  • one of the following constitutional symptoms (fatigue, headache, myalgia, feverishness) that is considered by the patient to be moderate or severe (greater than mild severity).
  • Confirmation of influenza A or B infection in the local community by one of the following means:
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  • the institution's local laboratory, or
  • the local public health system, or
  • the national public health system, or
  • a laboratory of a recognized national or multinational influenza surveillance scheme.
  • Onset of illness no more than 48 hours before enrollment in the trial.
  • Note: Time of onset of illness is defined as either the earlier of:
  • the time when the temperature was first measured as elevated, OR
  • the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom.
  • Willing and able to provide written informed consent (including assent by legal guardian if under 18 years of age) and comply with the requirements of the protocol, including completion of the patient diary.

Who cannot join

  • Severity of illness requiring or anticipated to require in-hospital care or subject defined as being at high risk of complications from influenza infection according to the Infectious Diseases Society of America (IDSA) guidelines for seasonal influenza in adults and children (Committee of Infectious Diseases (CID) 2009:48) or current Centers for Disease Control and Prevention (CDC) criteria. Current criteria for persons 13-65 years of age who are at risk of influenza complications include (list to be reviewed and updated as required prior to initiation of the study and at least monthly during the study):
  • Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults.
  • Persons with hemodynamically significant cardiac disease.
  • Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy.
  • HIV-infected persons.
  • Persons with sickle cell anemia or other hemoglobinopathies.
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  • Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease.
  • Persons with chronic renal dysfunction.
  • Persons with liver disorders.
  • Persons with cancer.
  • Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders.
  • Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions.
  • Residents of any age of nursing homes or other long-term care institutions.
  • Persons who are morbidly obese (Body Mass Index ≥40)
  • American Indians (seemed to be at higher risk of complications last flu season)
  • Alaskan natives (seemed to be at higher risk of complications last flu season)
  • Females of childbearing potential who are either pregnant, breast-feeding or are sexually active without the use of birth control. Female patients of child-bearing potential that are sexually active must have a negative baseline pregnancy test and must agree to continue an acceptable method of birth control for the duration of the study and for 1 month post-treatment. A double barrier method, oral birth control pills administered for at least 2 monthly cycles prior to study drug administration, an intrauterine device (IUD), or medroxyprogesterone acetate administered intramuscularly for a minimum of one month prior to study drug administration are acceptable methods of birth control for inclusion into the study. Female subjects are considered of childbearing potential unless they are postmenopausal (absence of menstrual bleeding for 1 year - or 6 months if laboratory confirmation of hormonal status), or have had a hysterectomy, bilateral tubular ligation or bilateral ovariectomy.
  • Vaccination for seasonal influenza on or after i. August 1, 2012 in the case of subjects enrolled during the 2012/2013 flu season in the United States, ii. February 1, 2013 in the case of subjects enrolled during the 2013 flu season in Australia or New Zealand, or iii. August 1, 2013 in the case of subjects enrolled during the 2013/2014 flu season in the United States, Canada, Europe, or other countries in the Northern Hemisphere, or iv. February 1, 2014 in the case of subjects enrolled during the 2014 flu season in Australia or New Zealand, or v. August 1, 2014 in the case of subjects enrolled during the 2014/2015 flu season in the United States, Canada, Europe, or other countries in the Northern Hemisphere.
  • Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, amantadine, or rimantadine within 30 days prior to screening.
  • Prior treatment with any investigational drug therapy within 30 days prior to screening.
  • Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.
  • Known sensitivity to Nitazoxanide or any of the excipients comprising the Nitazoxanide tablets.
  • Known sensitivity to Oseltamivir or any of the excipients comprising the Oseltamivir capsules.
  • Subjects unable to take oral medications.
  • Subject has chronic kidney or liver disease (including Hepatitis A,B or C) or known impaired hepatic and/or renal function.
  • Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.
  • Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in this study.
  • Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Trial locations and contacts

167 sites in 5 countries.

167 sites in 5 countries

United States136 sites

  • Influence Study Site

    Albuquerque, New Mexico, 87102

  • Influence Study Site

    Alexandria, Virginia, 22304

  • Influence Study Site

    Altoona, Pennsylvania, 16602

  • Influence Study Site

    Anaheim, California, 92805

  • Influence Study Site

    Ann Arbor, Michigan, 48105

  • Influence Study Site

    Ashburn, Virginia, 20147

  • Influence Study Site

    Ashland, Oregon, 97520

  • Influence Study Site

    Atlanta, Georgia, 30312

  • Influence Study Site

    Augusta, Kansas, 67010

  • Influence Study Site

    Austin, Texas, 78758

  • Influence Study Site

    Beaumont, Texas, 77701

  • Influence Study Site

    Birmingham, Alabama, 35209

  • Influence Study Site

    Blackfoot, Idaho, 83221

  • Influence Study Site

    Boynton Beach, Florida, 33472

  • Influence Study Site

    Bridgeton, Missouri, 63044

  • Influence Study Site

    Bristol, Tennessee, 37620

  • Influence Study Site

    Brooklyn, New York, 11203

  • Influence Study Site

    Brooklyn, New York, 11206

  • Influence Study Site

    Bryan, Texas, 77802

  • Influence Study Site

    Canton, Georgia, 30114

  • Influence Study Site

    Centennial, Colorado, 80112

  • Influence Study Site

    Charleston, South Carolina, 29412

  • Influence Study Site

    Charlotte, North Carolina, 25205

  • Influence Study Site

    Charlotte, North Carolina, 28209

  • Influence Study Site

    Charlottesville, Virginia, 22908

  • Influence Study Site

    Chelsea, Michigan, 48118

  • Influence Study Site

    Colorado Springs, Colorado, 80906

  • Influence Study Site

    Colorado Springs, Colorado, 80920

  • Influence Study Site

    Columbia, Tennessee, 38401

  • Influence Study Site

    Columbus, Georgia, 31904

  • Influence Study Site

    Columbus, Ohio, 43214

  • Influence Study Site

    Coral Gables, Florida, 33134

  • Influence Study Site

    Dayton, Ohio, 45432

  • Influence Study Site

    Dothan, Alabama, 36305

  • Influence Study Site

    Draper, Utah, 84020

  • Influence Study Site

    Edgewater, Florida, 32132

  • Influence Study Site

    Elizabethton, Tennessee, 37643

  • Influence Study Site

    Essexville, Michigan, 48732

  • Influence Study Site

    Eunice, Louisiana, 70535

  • Influence Study Site

    Evansville, Indiana, 47725

  • Influence Study Site

    Fall River, Massachusetts, 02720

  • Influence Study Site

    Franklin, Indiana, 46131

  • Influence Study Site

    Franklin, Tennessee, 37067

  • Influence Study Site

    Fremont, Nebraska, 68025

  • Influence Study Site

    Fresno, California, 93726

  • Influence Study Site

    Gainesville, Virginia, 20155

  • Influence Study Site

    Garden Grove, California, 92844

  • Influence Study Site

    Great Neck, New York, 11023

  • Influence Study Site

    Gresham, Oregon, 97030

  • Influence Study Site

    Groveport, Ohio, 43125

  • Influence Study Site

    Harbor City, California, 90710

  • Influence Study Site

    Hawesville, Kentucky, 42348

  • Influence Study Site

    Hickory, North Carolina, 28602

  • Influence Study Site

    Hoover, Alabama, 35216

  • Influence Study Site

    Hot Springs, Arkansas, 71913

  • Influence Study Site

    Houston, Texas, 77055

  • Influence Study Site

    Houston, Texas, 77062

  • Influence Study Site

    Huntington Beach, California, 92647

  • Influence Study Site

    Irving, Texas, 75039

  • Influence Study Site

    Jackson, Tennessee, 38305

  • Influence Study Site

    Jonesboro, Arkansas, 72401

  • Influence Study Site

    Kansas City, Kansas, 64133

  • Influence Study Site

    Kissimmee, Florida, 34741

  • Influence Study Site

    La Crosse, Wisconsin, 54601

  • Influence Study Site

    Lafayette, Louisiana, 70503

  • Influence Study Site

    Lake Charles, Louisiana, 70601

  • Influence Study Site

    Lake Jackson, Texas, 77566

  • Influence Study Site

    Lansdale, Pennsylvania, 19446

  • Influence Study Site

    Las Vegas, Nevada, 89102

  • Influence Study Site

    Las Vegas, Nevada, 89128

  • Influence Study Site

    Lauderdale Lakes, Florida, 33319

  • Influence Study Site

    Littleton, Colorado, 80128

  • Influence Study Site

    Lomita, California, 90719

  • Influence Study Site

    Long Beach, California, 98013

  • Influence Study Site

    Longmont, Colorado, 80501

  • Influence Study Site

    Lyndhurst, Ohio, 44124

  • Influence Study Site

    Madisonville, Kentucky, 42431

  • Influence Study Site

    Magna, Utah, 84044

  • Influence Study Site

    Mesa, Arizona, 85206

  • Influence Study Site

    Mesa, Arizona, 85213

  • Influence Study Site

    Miami, Florida, 33174

  • Influence Study Site

    Middleburg Heights, Ohio, 44130

  • Influence Study Site

    Midlothian, Virginia, 23114

  • Influence Study Site

    Milford, Ohio, 45150

  • Influence Study Site

    Mobile, Alabama, 36608

  • Influence Study Site

    Modesto, California, 95350

  • Influence Study Site

    Mooresville, North Carolina, 28117

  • Influence Study Site

    Muncie, Indiana, 47301

  • Influence Study Site

    New York, New York, 10016

  • Influence Study Site

    Newton, Kansas, 67114

  • Influence Study Site

    Niles, Michigan, 49120

  • Influence Study Site

    Norco, California, 92860

  • Influence Study Site

    Norfolk, Virginia, 23507

  • Influence Study Site

    North Richland Hills, Texas, 76180

  • Influence Study Site

    Orem, Utah, 84058

  • Influence Study Site

    Orlando, Florida, 32806

  • Influence Study Site

    Owensboro, Kentucky, 42303

  • Influence Study Site

    Pembroke Pines, Florida, 33028

  • Influence Study Site

    Pharr, Texas, 78577

  • Influence Study Site

    Pittsburgh, Pennsylvania, 15212

  • Influence Study Site

    Pittsburgh, Pennsylvania, 15236

  • Influence Study Site

    Plano, Texas, 75024

  • Influence Study Site

    Port Orchard, Washington, 98366

  • Influence Study Site

    Rapid City, South Dakota, 57701

  • Influence Study Site

    Rapid City, South Dakota, 57702

  • Influence Study Site

    Reading, Pennsylvania, 19606

  • Influence Study Site

    Rochester, New York, 14642

  • Influence Study Site

    Saint Cloud, Florida, 34769

  • Influence Study Site

    Salt Lake City, Utah, 84117

  • Influence Study Site

    San Antonio, Texas, 77566

  • Influence Study Site

    San Antonio, Texas, 78207

  • Influence Study Site

    San Antonio, Texas, 78258

  • Influence Study Site

    San Ramon, California, 94582

  • Influence Study Site

    Scottdale, Pennsylvania, 15683

  • Influence Study Site

    Skokie, Illinois, 60077

  • Influence Study Site

    Smyrna, Tennessee, 37167

  • Influence Study Site

    Spokane, Washington, 99202

  • Influence Study Site

    Spokane, Washington, 99218

  • Influence Study Site

    Stockton, California, 95204

  • Influence Study Site

    Sugar Land, Texas, 77479

  • Influence Study Site

    Teaneck, New Jersey, 07666

  • Influence Study Site

    Thornton, Colorado, 80233

  • Influence Study Site

    Troy, Michigan, 48098

  • Influence Study Site

    Tucson, Arizona, 85741

  • Influence Study Site

    Tulsa, Oklahoma, 74136

  • Influence Study Site

    Uniontown, Pennsylvania, 15401

  • Influence Study Site

    Virginia Beach, Virginia, 23455

  • Influence Study Site

    Waco, Texas, 76712

  • Influence Study Site

    Warwick, Rhode Island, 02886

  • Influence Study Site

    West Palm Beach, Florida, 33406

  • Influence Study Site

    Westfield, New York, 14787

  • Influence Study Site

    Wichita, Kansas, 67205

  • Influence Study Site

    Wichita, Kansas, 67207

  • Influence Study Site

    Willoughby Hills, Ohio, 44094

  • Influence Study Site

    Winston-Salem, North Carolina, 27103

  • Influence Study Site

    Wooster, Ohio, 44691

Other trials in United States

Canada12 sites

  • Influence Study Site

    Brampton, Ontario, L6W2A4

  • Influence Study Site

    Coquitlam, British Columbia, V3K3P4

  • Influence Study Site

    Langley, British Columbia, V3A4H9

  • Influence Study Site

    London, Ontario, N5Y5K7

  • Influence Study Site

    Mirabel, Quebec, J7J2K8

  • Influence Study Site

    Montreal, Quebec, H1T2M4

  • Influence Study Site

    Niagara Falls, Ontario, L2E 6S5

  • Influence Study Site

    Pointe-Claire, Quebec, H9R4S3

  • Influence Study Site

    Sarnia, Ontario, N7T4X3

  • Influence Study Site

    Surrey, British Columbia, V3S2N6

  • Influence Study Site

    Toronto, Ontario, M4S1Y2

  • Influence Study Site

    Toronto, Ontario, M9W4L6

Other trials in Canada

Australia11 sites

  • Influence Study Site

    Cardiff, New South Wales, 2285

  • Influence Study Site

    Castle Hill, New South Wales, 2154

  • Influence Study Site

    Chermside, Queensland, 4032

  • Influence Study Site

    Clayton, Victoria, 3168

  • Influence Study Site

    Darlinghurst, New South Wales, 2010

  • Influence Study Site

    Daw Park, South Australia, 5041

  • Influence Study Site

    Fitzroy North, Victoria, 3068

  • Influence Study SIte

    Nedlands, Western Australia, 6009

  • Influence Study Site

    Prahran, Victoria, 3181

  • Influence Study Site

    Sherwood, Queensland, 4075

  • Influence Study Site

    Westmead, Sydney, New South Wales, 2145

Other trials in Australia

New Zealand7 sites

  • Influence Study Site

    Beckenham, Christchurch, 8061

  • Influence Study Site

    Birkenhead, Auckland, 626

  • Influence Study Site

    Christchurch Central, Christchurch, 8011

  • Influence Study Site

    Grafton, Auckland, 1010

  • Influence Study Site

    Remuera, Auckland, 1050

  • Influence Study Site

    Rotorua, Bay of Plenty, 3010

  • Influence Study Site

    Tauranga, Bay of Plenty, 3112

Other trials in New Zealand

Belgium1 site

  • Influence Study Site

    Antwerp, 2060

Other trials in Belgium

About this study

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

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.

Conditions
Influenza
Being tested
Nitazoxanide, Oseltamivir, Placebo Oral Tablet, Placebo Oral Capsule
Keywords
Influenza
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitazoxanideDrug

    Also called Alinia, NTZ (nitazoxanide)

  • OseltamivirDrug

    Also called Tamiflu, OST (oseltamivir)

  • Placebo Oral TabletDrug

  • Placebo Oral CapsuleDrug

Study groups in NCT01610245
Study groupRoleWhat they receive
NitazoxanideActive comparatorTwo Nitazoxanide 300 mg tablets and one placebo capsule twice daily with food for 5 days
Receives: Drug: Nitazoxanide; Drug: Placebo Oral Capsule
OseltamivirActive comparatorTwo placebo tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days
Receives: Drug: Oseltamivir; Drug: Placebo Oral Tablet
Nitazoxanide and OseltamivirActive comparatorTwo nitazoxanide 300 mg tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days
Receives: Drug: Nitazoxanide; Drug: Oseltamivir
PlaceboPlacebo comparatorTwo placebo tablets and one placebo capsule with food twice daily for 5 days
Receives: Drug: Placebo Oral Tablet; Drug: Placebo Oral Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to resolution of all clinical symptoms of influenza as reported by the subjects

    Measured: Up to 28 days

Secondary outcomes (1)

  1. Time to resolution of each individual symptom of influenza

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2012 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015
  4. Study completion16 Apr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,941 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01610245
Sponsor's protocol ID
RM08-3002
Status last verified
Mar 2018
First submitted
30 May 2012
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nitazoxanide and Oseltamivir in people with Influenza, run by Romark Laboratories L.C. at 167 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 167 sites in United States, Canada, Australia, New Zealand, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to resolution of all clinical symptoms of influenza as reported by the subjects (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01610245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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