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

Sponsor
Romark Laboratories L.C. (Industry)
Overall Status
Completed
CT.gov ID
NCT01610245
Collaborator
(none)
1,941
Enrollment
167
Locations
4
Arms
25.5
Duration (Months)
11.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1941 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Apr 16, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nitazoxanide

Two Nitazoxanide 300 mg tablets and one placebo capsule twice daily with food for 5 days

Drug: Nitazoxanide
Other Names:
  • Alinia
  • NTZ (nitazoxanide)

    • Drug: Placebo Oral Capsule
    Active Comparator: Oseltamivir

    Two placebo tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days

    Drug: Oseltamivir
    Other Names:
  • Tamiflu
  • OST (oseltamivir)

    • Drug: Placebo Oral Tablet
    Active Comparator: Nitazoxanide and Oseltamivir

    Two nitazoxanide 300 mg tablets and one Oseltamivir 75 mg capsule twice daily with food for 5 days

    Drug: Nitazoxanide
    Other Names:
  • Alinia
  • NTZ (nitazoxanide)

    • Drug: Oseltamivir
    Other Names:
  • Tamiflu
  • OST (oseltamivir)

    		•
    Placebo Comparator: Placebo

    Two placebo tablets and one placebo capsule with food twice daily for 5 days

    Drug: Placebo Oral Tablet

    Drug: Placebo Oral Capsule

    Outcome Measures

    Primary Outcome Measures

    1. Time to resolution of all clinical symptoms of influenza as reported by the subjects [Up to 28 days]

    Secondary Outcome Measures

    1. Time to resolution of each individual symptom of influenza [Up to 28 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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):

    3. 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

    4. 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

    5. 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).

    6. Confirmation of influenza A or B infection in the local community by one of the following means:

    7. the institution's local laboratory, or

    8. the local public health system, or

    9. the national public health system, or

    10. a laboratory of a recognized national or multinational influenza surveillance scheme.

    11. 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.

    3. 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):

    2. Persons with asthma or other chronic pulmonary diseases, such as cystic fibrosis in children or chronic obstructive pulmonary disease in adults.

    3. Persons with hemodynamically significant cardiac disease.

    4. Persons who have immunosuppressive disorders or who are receiving immunosuppressive therapy.

    5. HIV-infected persons.

    6. Persons with sickle cell anemia or other hemoglobinopathies.

    7. Persons with diseases requiring long-term aspirin therapy, such as rheumatoid arthritis or Kawasaki disease.

    8. Persons with chronic renal dysfunction.

    9. Persons with liver disorders.

    10. Persons with cancer.

    11. Persons with chronic metabolic disease, such as diabetes mellitus, inherited metabolic disorders and mitochondrial disorders.

    12. Persons with neuromuscular disorders, seizure disorders or cognitive dysfunction that may compromise the handling of respiratory secretions.

    13. Residents of any age of nursing homes or other long-term care institutions.

    14. Persons who are morbidly obese (Body Mass Index ≥40)

    15. American Indians (seemed to be at higher risk of complications last flu season)

    16. Alaskan natives (seemed to be at higher risk of complications last flu season)

    17. 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.

    18. 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.

    19. Receipt of any dose of nitazoxanide, oseltamivir, zanamivir, amantadine, or rimantadine within 30 days prior to screening.

    20. Prior treatment with any investigational drug therapy within 30 days prior to screening.

    21. Subjects with active respiratory allergies or subjects expected to require anti-allergy medications during the study period for respiratory allergies.

    22. Known sensitivity to Nitazoxanide or any of the excipients comprising the Nitazoxanide tablets.

    23. Known sensitivity to Oseltamivir or any of the excipients comprising the Oseltamivir capsules.

    24. Subjects unable to take oral medications.

    25. Subject has chronic kidney or liver disease (including Hepatitis A,B or C) or known impaired hepatic and/or renal function.

    26. Presence of any other pre-existing chronic infection that is undergoing or requiring medical therapy.

    27. 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.

    28. Subjects who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Influence Study Site Birmingham Alabama United States 35209
    2 Influence Study Site Dothan Alabama United States 36305
    3 Influence Study Site Hoover Alabama United States 35216
    4 Influence Study Site Mobile Alabama United States 36608
    5 Influence Study Site Mesa Arizona United States 85206
    6 Influence Study Site Mesa Arizona United States 85213
    7 Influence Study Site Tucson Arizona United States 85741
    8 Influence Study Site Hot Springs Arkansas United States 71913
    9 Influence Study Site Jonesboro Arkansas United States 72401
    10 Influence Study Site Anaheim California United States 92805
    11 Influence Study Site Fresno California United States 93726
    12 Influence Study Site Garden Grove California United States 92844
    13 Influence Study Site Harbor City California United States 90710
    14 Influence Study Site Huntington Beach California United States 92647
    15 Influence Study Site Lomita California United States 90719
    16 Influence Study Site Long Beach California United States 98013
    17 Influence Study Site Modesto California United States 95350
    18 Influence Study Site Norco California United States 92860
    19 Influence Study Site San Ramon California United States 94582
    20 Influence Study Site Stockton California United States 95204
    21 Influence Study Site Centennial Colorado United States 80112
    22 Influence Study Site Colorado Springs Colorado United States 80906
    23 Influence Study Site Colorado Springs Colorado United States 80920
    24 Influence Study Site Littleton Colorado United States 80128
    25 Influence Study Site Longmont Colorado United States 80501
    26 Influence Study Site Thornton Colorado United States 80233
    27 Influence Study Site Boynton Beach Florida United States 33472
    28 Influence Study Site Coral Gables Florida United States 33134
    29 Influence Study Site Edgewater Florida United States 32132
    30 Influence Study Site Kissimmee Florida United States 34741
    31 Influence Study Site Lauderdale Lakes Florida United States 33319
    32 Influence Study Site Miami Florida United States 33174
    33 Influence Study Site Orlando Florida United States 32806
    34 Influence Study Site Pembroke Pines Florida United States 33028
    35 Influence Study Site Saint Cloud Florida United States 34769
    36 Influence Study Site West Palm Beach Florida United States 33406
    37 Influence Study Site Atlanta Georgia United States 30312
    38 Influence Study Site Canton Georgia United States 30114
    39 Influence Study Site Columbus Georgia United States 31904
    40 Influence Study Site Blackfoot Idaho United States 83221
    41 Influence Study Site Skokie Illinois United States 60077
    42 Influence Study Site Evansville Indiana United States 47725
    43 Influence Study Site Franklin Indiana United States 46131
    44 Influence Study Site Muncie Indiana United States 47301
    45 Influence Study Site Augusta Kansas United States 67010
    46 Influence Study Site Kansas City Kansas United States 64133
    47 Influence Study Site Newton Kansas United States 67114
    48 Influence Study Site Wichita Kansas United States 67205
    49 Influence Study Site Wichita Kansas United States 67207
    50 Influence Study Site Hawesville Kentucky United States 42348
    51 Influence Study Site Madisonville Kentucky United States 42431
    52 Influence Study Site Owensboro Kentucky United States 42303
    53 Influence Study Site Eunice Louisiana United States 70535
    54 Influence Study Site Lafayette Louisiana United States 70503
    55 Influence Study Site Lake Charles Louisiana United States 70601
    56 Influence Study Site Fall River Massachusetts United States 02720
    57 Influence Study Site Ann Arbor Michigan United States 48105
    58 Influence Study Site Chelsea Michigan United States 48118
    59 Influence Study Site Essexville Michigan United States 48732
    60 Influence Study Site Niles Michigan United States 49120
    61 Influence Study Site Troy Michigan United States 48098
    62 Influence Study Site Bridgeton Missouri United States 63044
    63 Influence Study Site Fremont Nebraska United States 68025
    64 Influence Study Site Las Vegas Nevada United States 89102
    65 Influence Study Site Las Vegas Nevada United States 89128
    66 Influence Study Site Teaneck New Jersey United States 07666
    67 Influence Study Site Albuquerque New Mexico United States 87102
    68 Influence Study Site Brooklyn New York United States 11203
    69 Influence Study Site Brooklyn New York United States 11206
    70 Influence Study Site Great Neck New York United States 11023
    71 Influence Study Site New York New York United States 10016
    72 Influence Study Site Rochester New York United States 14642
    73 Influence Study Site Westfield New York United States 14787
    74 Influence Study Site Charlotte North Carolina United States 25205
    75 Influence Study Site Charlotte North Carolina United States 28209
    76 Influence Study Site Hickory North Carolina United States 28602
    77 Influence Study Site Mooresville North Carolina United States 28117
    78 Influence Study Site Winston-Salem North Carolina United States 27103
    79 Influence Study Site Columbus Ohio United States 43214
    80 Influence Study Site Dayton Ohio United States 45432
    81 Influence Study Site Groveport Ohio United States 43125
    82 Influence Study Site Lyndhurst Ohio United States 44124
    83 Influence Study Site Middleburg Heights Ohio United States 44130
    84 Influence Study Site Milford Ohio United States 45150
    85 Influence Study Site Willoughby Hills Ohio United States 44094
    86 Influence Study Site Wooster Ohio United States 44691
    87 Influence Study Site Tulsa Oklahoma United States 74136
    88 Influence Study Site Ashland Oregon United States 97520
    89 Influence Study Site Gresham Oregon United States 97030
    90 Influence Study Site Altoona Pennsylvania United States 16602
    91 Influence Study Site Lansdale Pennsylvania United States 19446
    92 Influence Study Site Pittsburgh Pennsylvania United States 15212
    93 Influence Study Site Pittsburgh Pennsylvania United States 15236
    94 Influence Study Site Reading Pennsylvania United States 19606
    95 Influence Study Site Scottdale Pennsylvania United States 15683
    96 Influence Study Site Uniontown Pennsylvania United States 15401
    97 Influence Study Site Warwick Rhode Island United States 02886
    98 Influence Study Site Charleston South Carolina United States 29412
    99 Influence Study Site Rapid City South Dakota United States 57701
    100 Influence Study Site Rapid City South Dakota United States 57702
    101 Influence Study Site Bristol Tennessee United States 37620
    102 Influence Study Site Columbia Tennessee United States 38401
    103 Influence Study Site Elizabethton Tennessee United States 37643
    104 Influence Study Site Franklin Tennessee United States 37067
    105 Influence Study Site Jackson Tennessee United States 38305
    106 Influence Study Site Smyrna Tennessee United States 37167
    107 Influence Study Site Austin Texas United States 78758
    108 Influence Study Site Beaumont Texas United States 77701
    109 Influence Study Site Bryan Texas United States 77802
    110 Influence Study Site Houston Texas United States 77055
    111 Influence Study Site Houston Texas United States 77062
    112 Influence Study Site Irving Texas United States 75039
    113 Influence Study Site Lake Jackson Texas United States 77566
    114 Influence Study Site North Richland Hills Texas United States 76180
    115 Influence Study Site Pharr Texas United States 78577
    116 Influence Study Site Plano Texas United States 75024
    117 Influence Study Site San Antonio Texas United States 77566
    118 Influence Study Site San Antonio Texas United States 78207
    119 Influence Study Site San Antonio Texas United States 78258
    120 Influence Study Site Sugar Land Texas United States 77479
    121 Influence Study Site Waco Texas United States 76712
    122 Influence Study Site Draper Utah United States 84020
    123 Influence Study Site Magna Utah United States 84044
    124 Influence Study Site Orem Utah United States 84058
    125 Influence Study Site Salt Lake City Utah United States 84117
    126 Influence Study Site Alexandria Virginia United States 22304
    127 Influence Study Site Ashburn Virginia United States 20147
    128 Influence Study Site Charlottesville Virginia United States 22908
    129 Influence Study Site Gainesville Virginia United States 20155
    130 Influence Study Site Midlothian Virginia United States 23114
    131 Influence Study Site Norfolk Virginia United States 23507
    132 Influence Study Site Virginia Beach Virginia United States 23455
    133 Influence Study Site Port Orchard Washington United States 98366
    134 Influence Study Site Spokane Washington United States 99202
    135 Influence Study Site Spokane Washington United States 99218
    136 Influence Study Site La Crosse Wisconsin United States 54601
    137 Influence Study Site Cardiff New South Wales Australia 2285
    138 Influence Study Site Castle Hill New South Wales Australia 2154
    139 Influence Study Site Darlinghurst New South Wales Australia 2010
    140 Influence Study Site Westmead, Sydney New South Wales Australia 2145
    141 Influence Study Site Chermside Queensland Australia 4032
    142 Influence Study Site Sherwood Queensland Australia 4075
    143 Influence Study Site Daw Park South Australia Australia 5041
    144 Influence Study Site Clayton Victoria Australia 3168
    145 Influence Study Site Fitzroy North Victoria Australia 3068
    146 Influence Study Site Prahran Victoria Australia 3181
    147 Influence Study SIte Nedlands Western Australia Australia 6009
    148 Influence Study Site Antwerpen Belgium 2060
    149 Influence Study Site Coquitlam British Columbia Canada V3K3P4
    150 Influence Study Site Langley British Columbia Canada V3A4H9
    151 Influence Study Site Surrey British Columbia Canada V3S2N6
    152 Influence Study Site Brampton Ontario Canada L6W2A4
    153 Influence Study Site London Ontario Canada N5Y5K7
    154 Influence Study Site Niagara Falls Ontario Canada L2E 6S5
    155 Influence Study Site Sarnia Ontario Canada N7T4X3
    156 Influence Study Site Toronto Ontario Canada M4S1Y2
    157 Influence Study Site Toronto Ontario Canada M9W4L6
    158 Influence Study Site Mirabel Quebec Canada J7J2K8
    159 Influence Study Site Montreal Quebec Canada H1T2M4
    160 Influence Study Site Pointe-Claire Quebec Canada H9R4S3
    161 Influence Study Site Birkenhead Auckland New Zealand 626
    162 Influence Study Site Grafton Auckland New Zealand 1010
    163 Influence Study Site Remuera Auckland New Zealand 1050
    164 Influence Study Site Rotorua Bay Of Plenty New Zealand 3010
    165 Influence Study Site Tauranga Bay Of Plenty New Zealand 3112
    166 Influence Study Site Beckenham Christchurch New Zealand 8061
    167 Influence Study Site Christchurch Central Christchurch New Zealand 8011

    Sponsors and Collaborators

    • Romark Laboratories L.C.

    Investigators

    • Study Director: Jean-Francois Rossignol, M.D., Ph.D., Romark Laboratories L.C.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Romark Laboratories L.C.
    ClinicalTrials.gov Identifier:
    NCT01610245
    Other Study ID Numbers:
    • RM08-3002
    First Posted:
    Jun 1, 2012
    Last Update Posted:
    Mar 29, 2018
    Last Verified:
    Mar 1, 2018
    Keywords provided by Romark Laboratories L.C.
    Influenza
    Additional relevant MeSH terms:
    Influenza, Human
    Oseltamivir
    Nitazoxanide

    Study Results

    No Results Posted as of Mar 29, 2018