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

Information source: Romark Laboratories L.C.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza

Intervention: Nitazoxanide (Drug); Oseltamivir (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Romark Laboratories L.C.

Official(s) and/or principal investigator(s):
Jean-Francois Rossignol, M.D., Ph.D., Study Director, Affiliation: Romark Laboratories L.C.

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 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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time to resolution of all clinical symptoms of influenza as reported by the subjects

Secondary outcome: Time to resolution of each individual symptom of influenza

Eligibility

Minimum age: 13 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Age 13 to 65 years 2. Presence of clinical signs and/or symptoms consistent with acute illness compatible with influenza infection (each of the following is required): 1. 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 2. 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 3. 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). 3. Confirmation of influenza A or B infection in the local community by one of the following means: 1. the institution's local laboratory, or 2. the local public health system, or 3. the national public health system, or 4. a laboratory of a recognized national or multinational influenza surveillance scheme. 4. 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: 1. the time when the temperature was first measured as elevated, OR 2. the time when the subject experienced the presence of at least one respiratory symptom AND the presence of at least one constitutional symptom. 5. 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. Exclusion Criteria: 1. 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): 1. Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults. 2. Persons with hemodynamically significant cardiac disease. 3. Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy. 4. HIV-infected persons. 5. Persons with sickle cell anemia or other hemoglobinopathies. 6. Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease. 7. Persons with chronic renal dysfunction. 8. Persons with liver disorders. 9. Persons with cancer. 10. Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders. 11. Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions. 12. Residents of any age of nursing homes or other long-term care institutions. 13. Persons who are morbidly obese (Body Mass Index ≥40) 14. American Indians (seemed to be at higher risk of complications last flu season) 15. Alaskan natives (seemed to be at higher risk of complications last flu season) 2. 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. 3. 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. 4. Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, amantadine, or rimantidine within 30 days prior to screening. 5. Prior treatment with any investigational drug therapy within 30 days prior to screening. 6. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies. 7. Known sensitivity to Nitazoxanide or any of the excipients comprising the Nitazoxanide tablets. 8. Known sensitivity to Oseltamivir or any of the excipients comprising the Oseltamivir capsules. 9. Subjects unable to take oral medications. 10. Subject has chronic kidney or liver disease (including Hepatitis A,B or C) or known impaired hepatic and/or renal function. 11. Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy. 12. 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. 13. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

Locations and Contacts

Influence Study Site, Antwerpen 2060, Belgium

Influence Study Site, Birmingham, Alabama 35209, United States

Influence Study Site, Dothan, Alabama 36305, United States

Influence Study Site, Hoover, Alabama 35216, United States

Influence Study Site, Mobile, Alabama 36608, United States

Influence Study Site, Mesa, Arizona 85206, United States

Influence Study Site, Mesa, Arizona 85213, United States

Influence Study Site, Tucson, Arizona 85741, United States

Influence Study Site, Hot Springs, Arkansas 71913, United States

Influence Study Site, Jonesboro, Arkansas 72401, United States

Influence Study Site, Birkenhead, Auckland 626, New Zealand

Influence Study Site, Grafton, Auckland 1010, New Zealand

Influence Study Site, Remuera, Auckland 1050, New Zealand

Influence Study Site, Rotorua, Bay of Plenty 3010, New Zealand

Influence Study Site, Tauranga, Bay of Plenty 3112, New Zealand

Influence Study Site, Coquitlam, British Columbia V3K3P4, Canada

Influence Study Site, Langley, British Columbia V3A4H9, Canada

Influence Study Site, Surrey, British Columbia V3S2N6, Canada

Influence Study Site, Anaheim, California 92805, United States

Influence Study Site, Fresno, California 93726, United States

Influence Study Site, Garden Grove, California 92844, United States

Influence Study Site, Harbor City, California 90710, United States

Influence Study Site, Huntington Beach, California 92647, United States

Influence Study Site, Lomita, California 90719, United States

Influence Study Site, Long Beach, California 98013, United States

Influence Study Site, Modesto, California 95350, United States

Influence Study Site, Norco, California 92860, United States

Influence Study Site, San Ramon, California 94582, United States

Influence Study Site, Stockton, California 95204, United States

Influence Study Site, Beckenham, Christchurch 8061, New Zealand

Influence Study Site, Christchurch Central, Christchurch 8011, New Zealand

Influence Study Site, Centennial, Colorado 80112, United States

Influence Study Site, Colorado Springs, Colorado 80906, United States

Influence Study Site, Colorado Springs, Colorado 80920, United States

Influence Study Site, Littleton, Colorado 80128, United States

Influence Study Site, Longmont, Colorado 80501, United States

Influence Study Site, Thornton, Colorado 80233, United States

Influence Study Site, Boynton Beach, Florida 33472, United States

Influence Study Site, Coral Gables, Florida 33134, United States

Influence Study Site, Edgewater, Florida 32132, United States

Influence Study Site, Kissimmee, Florida 34741, United States

Influence Study Site, Lauderdale Lakes, Florida 33319, United States

Influence Study Site, Miami, Florida 33174, United States

Influence Study Site, Orlando, Florida 32806, United States

Influence Study Site, Pembroke Pines, Florida 33028, United States

Influence Study Site, St. Cloud, Florida 34769, United States

Influence Study Site, West Palm Beach, Florida 33406, United States

Influence Study Site, Atlanta, Georgia 30312, United States

Influence Study Site, Canton, Georgia 30114, United States

Influence Study Site, Columbus, Georgia 31904, United States

Influence Study Site, Blackfoot, Idaho 83221, United States

Influence Study Site, Skokie, Illinois 60077, United States

Influence Study Site, Evansville, Indiana 47725, United States

Influence Study Site, Franklin, Indiana 46131, United States

Influence Study Site, Muncie, Indiana 47301, United States

Influence Study Site, Augusta, Kansas 67010, United States

Influence Study Site, Kansas City, Kansas 64133, United States

Influence Study Site, Newton, Kansas 67114, United States

Influence Study Site, Wichita, Kansas 67205, United States

Influence Study Site, Wichita, Kansas 67207, United States

Influence Study Site, Hawesville, Kentucky 42348, United States

Influence Study Site, Madisonville, Kentucky 42431, United States

Influence Study Site, Owensboro, Kentucky 42303, United States

Influence Study Site, Eunice, Louisiana 70535, United States

Influence Study Site, LaFayette, Louisiana 70503, United States

Influence Study Site, Lake Charles, Louisiana 70601, United States

Influence Study Site, Fall River, Massachusetts 02720, United States

Influence Study Site, Ann Arbor, Michigan 48105, United States

Influence Study Site, Chelsea, Michigan 48118, United States

Influence Study Site, Essexville, Michigan 48732, United States

Influence Study Site, Niles, Michigan 49120, United States

Influence Study Site, Troy, Michigan 48098, United States

Influence Study Site, Bridgeton, Missouri 63044, United States

Influence Study Site, Fremont, Nebraska 68025, United States

Influence Study Site, Las Vegas, Nevada 89102, United States

Influence Study Site, Las Vegas, Nevada 89128, United States

Influence Study Site, Teaneck, New Jersey 07666, United States

Influence Study Site, Albuquerque, New Mexico 87102, United States

Influence Study Site, Cardiff, New South Wales 2285, Australia

Influence Study Site, Castle Hill, New South Wales 2154, Australia

Influence Study Site, Darlinghurst, New South Wales 2010, Australia

Influence Study Site, Westmead, Sydney, New South Wales 2145, Australia

Influence Study Site, Brooklyn, New York 11206, United States

Influence Study Site, Brooklyn, New York 11203, United States

Influence Study Site, Great Neck, New York 11023, United States

Influence Study Site, New York, New York 10016, United States

Influence Study Site, Rochester, New York 14642, United States

Influence Study Site, Westfield, New York 14787, United States

Influence Study Site, Charlotte, North Carolina 25205, United States

Influence Study Site, Charlotte, North Carolina 28209, United States

Influence Study Site, Hickory, North Carolina 28602, United States

Influence Study Site, Mooresville, North Carolina 28117, United States

Influence Study Site, Winston-Salem, North Carolina 27103, United States

Influence Study Site, Columbus, Ohio 43214, United States

Influence Study Site, Dayton, Ohio 45432, United States

Influence Study Site, Groveport, Ohio 43125, United States

Influence Study Site, Lyndhurst, Ohio 44124, United States

Influence Study Site, Middleburg Heights, Ohio 44130, United States

Influence Study Site, Milford, Ohio 45150, United States

Influence Study Site, Willoughby Hills, Ohio 44094, United States

Influence Study Site, Wooster, Ohio 44691, United States

Influence Study Site, Tulsa, Oklahoma 74136, United States

Influence Study Site, Brampton, Ontario L6W2A4, Canada

Influence Study Site, London, Ontario N5Y5K7, Canada

Influence Study Site, Niagara Falls, Ontario L2E 6S5, Canada

Influence Study Site, Sarnia, Ontario N7T4X3, Canada

Influence Study Site, Toronto, Ontario M9W4L6, Canada

Influence Study Site, Toronto, Ontario M4S1Y2, Canada

Influence Study Site, Ashland, Oregon 97520, United States

Influence Study Site, Gresham, Oregon 97030, United States

Influence Study Site, Altoona, Pennsylvania 16602, United States

Influence Study Site, Landsdale, Pennsylvania 19446, United States

Influence Study Site, Pittsburg, Pennsylvania 15212, United States

Influence Study Site, Pittsburg, Pennsylvania 15236, United States

Influence Study Site, Reading, Pennsylvania 19606, United States

Influence Study Site, Scottsdale, Pennsylvania 15683, United States

Influence Study Site, Uniontown, Pennsylvania 15401, United States

Influence Study Site, Mirabel, Quebec J7J2K8, Canada

Influence Study Site, Montreal, Quebec H1T2M4, Canada

Influence Study Site, Pointe-Claire, Quebec H9R4S3, Canada

Influence Study Site, Chermside, Queensland 4032, Australia

Influence Study Site, Sherwood, Queensland 4075, Australia

Influence Study Site, Warwick, Rhode Island 02886, United States

Influence Study Site, Daw Park, South Australia 5041, Australia

Influence Study Site, Charleston, South Carolina 29412, United States

Influence Study Site, Rapid City, South Dakota 57701, United States

Influence Study Site, Rapid City, South Dakota 57702, United States

Influence Study Site, Bristol, Tennessee 37620, United States

Influence Study Site, Columbia, Tennessee 38401, United States

Influence Study Site, Elizabethton, Tennessee 37643, United States

Influence Study Site, Franklin, Tennessee 37067, United States

Influence Study Site, Jackson, Tennessee 38305, United States

Influence Study Site, Smyrna, Tennessee 37167, United States

Influence Study Site, Austin, Texas 78758, United States

Influence Study Site, Beaumont, Texas 77701, United States

Influence Study Site, Bryan, Texas 77802, United States

Influence Study Site, Houston, Texas 77055, United States

Influence Study Site, Houston, Texas 77062, United States

Influence Study Site, Irving, Texas 75039, United States

Influence Study Site, Lake Jackson, Texas 77566, United States

Influence Study Site, North Richland Hills, Texas 76180, United States

Influence Study Site, Pharr, Texas 78577, United States

Influence Study Site, Plano, Texas 75024, United States

Influence Study Site, San Antonio, Texas 77566, United States

Influence Study Site, San Antonio, Texas 78207, United States

Influence Study Site, San Antonio, Texas 78258, United States

Influence Study Site, Sugarland, Texas 77479, United States

Influence Study Site, Waco, Texas 76712, United States

Influence Study Site, Draper, Utah 84020, United States

Influence Study Site, Magna, Utah 84044, United States

Influence Study Site, Orem, Utah 84058, United States

Influence Study Site, Salt Lake City, Utah 84117, United States

Influence Study Site, Clayton, Victoria 3168, Australia

Influence Study Site, Fitzroy North, Victoria 3068, Australia

Influence Study Site, Prahran, Victoria 3181, Australia

Influence Study Site, Alexandria, Virginia 22304, United States

Influence Study Site, Ashburn, Virginia 20147, United States

Influence Study Site, Charlottesville, Virginia 22908, United States

Influence Study Site, Gainesville, Virginia 20155, United States

Influence Study Site, Midlothian, Virginia 23114, United States

Influence Study Site, Norfolk, Virginia 23507, United States

Influence Study Site, Virginia Beach, Virginia 23455, United States

Influence Study Site, Port Orchard, Washington 98366, United States

Influence Study Site, Spokane, Washington 99202, United States

Influence Study Site, Spokane, Washington 99218, United States

Influence Study SIte, Nedlands, Western Australia 6009, Australia

Influence Study Site, Lacrosse, Wisconsin 54601, United States

Additional Information

Starting date: March 2013
Last updated: March 18, 2015

Page last updated: August 23, 2015

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