A Study of S-033188 Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza



Status:Active, not recruiting
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 64
Updated:4/1/2017
Start Date:November 2016
End Date:October 2017

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A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

The primary objective of this study is to evaluate the efficacy of a single, oral dose of
S-033188 compared with placebo by measuring the time to alleviation of symptoms in patients
with uncomplicated influenza virus infection.


Inclusion Criteria:

1. Patients who are able to understand the study and comply with all study procedures,
and willing to provide written informed consent/assent prior to the predose
examinations appropriately. As for adolescent patients, informed consent/assent of
voluntary participation should be obtained in accordance with local requirements

2. Male or female patients aged ≥ 12 to ≤ 64 years at the time of signing the informed
consent/assent form.

3. Patients with a diagnosis of influenza virus infection confirmed by all of the
following:

1. Fever ≥ 38ºC (axillary) in the predose examinations or > 4 hours after dosing of
antipyretics if they were taken

2. At least one of the following general systemic symptoms associated with
influenza are present with a severity of moderate or greater

- Headache

- Feverishness or chills

- Muscle or joint pain

- Fatigue

3. At least one of the following respiratory symptoms associated with influenza are
present with a severity of moderate or greater

- Cough

- Sore throat

- Nasal congestion

4. The time interval between the onset of symptoms and the predose examinations is 48
hours or less. The onset of symptoms is defined as either:

1. Time of the first increase in body temperature (an increase of at least 1ºC from
normal body temperature)

2. Time when the patient experiences at least one general or respiratory symptom

5. Women of childbearing potential who agree to use a highly effective method of
contraception for 3 months after the first dose of study drug

Exclusion Criteria:

1. Patients with severe influenza virus infection requiring inpatient treatment.

2. Patients aged ≥ 20 years with known allergy to oseltamivir (Tamiflu®).

3. Patients with any of the following risk factors

1. Women who are pregnant or within 2 weeks post-partum

2. Residents of long-term care facilities (eg, welfare facilities for the elderly,
nursing homes)

3. Chronic respiratory diseases including bronchial asthma

4. Neurological and neurodevelopmental disorders including disorders of the brain,
spinal cord, peripheral nerve, and muscle (eg, cerebral palsy, epilepsy [seizure
disorders], stroke, intellectual disability, moderate to severe developmental
delay, muscular dystrophy, or spinal cord injury)

5. Heart disease (such as congenital heart disease, congestive heart failure, or
coronary artery disease), excluding hypertension without any other heart-related
symptoms)

6. American Indians and Alaskan natives

7. Blood disorders (such as sickle cell disease)

8. Endocrine disorders (including diabetes mellitus)

9. Kidney disorders

10. Liver disorders

11. Metabolic disorders

12. Compromised immune system (including patients receiving immunosuppressant
therapy, or those with cancer or human immunodeficiency virus [HIV] infection)

13. Morbid obesity (body mass index [BMI] ≥ 40)

4. Patients unable to swallow tablets or capsules.

5. Patients who have previously received S-033188.

6. Patients weighing < 40 kg

7. Patients who have been exposed to an investigational drug within 30 days prior to the
predose examinations.

8. Women who are breastfeeding or have a positive pregnancy test in the predose
examinations. The following female patients who have documentation of either a or b
below do not need to undergo a pregnancy test in the predose examinations:

1. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or
more and confirmed by a follicle-stimulating hormone test) women

2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or
tubal ligation

9. Patients with concurrent infections requiring systemic antimicrobial and/or antiviral
therapy at the predose examinations.

10. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir,
rimantadine, umifenovir, or amantadine within 30 days prior to the predose
examinations.

11. Patients who have received an investigational monoclonal antibody for a viral disease
in the last year.

12. Patients with severe underlying diseases.

13. Patients with known creatinine clearance ≤ 60 mL/min.

14. Patients who, in the opinion of the investigator, would be unlikely to comply with
required study visits, self-assessments, and interventions
We found this trial at
117
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Dayton, Ohio
63
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Dayton, OH
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Addison, Texas 75001
905
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Addison, TX
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Athens, Alabama 35611
417
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Austin, Texas
1065
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Avon, Indiana 46123
179
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Avon, IN
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Baytown, Texas 77521
977
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Bellevue, Nebraska
679
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Bellevue, NE
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Berlin, New Jersey
428
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Birmingham, Alabama
491
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Boynton Beach, Florida
943
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Bozeman, Montana
1464
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Brampton, Ontario
?
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Brooklyn, New York 11201
280
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Canoga Park, California 91303
1987
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Canton, Ohio
103
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Carrollton, Texas 75010
908
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Centennial, Colorado 80249
1157
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Centerville, Ohio 45459
108
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Channelview, Texas
980
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Charleston, South Carolina
525
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Charlotte, North Carolina 28210
348
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Cincinnati, Ohio
99
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Clearwater, Florida
829
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Columbus, Georgia
529
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Corpus Christi, Texas 78413
1174
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Costa Mesa, California 92626
1965
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Dallas, Texas
911
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Decatur, Georgia
433
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Denver, Colorado
1162
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DeSoto, Texas 75115
922
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Diamond Bar, California 91765
1949
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Doral, Florida 33166
989
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Draper, Utah 84020
1514
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Ellensburg, Washington 98926
1922
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Evansville, Indiana
279
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Fayetteville, North Carolina 28314
408
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Fort Lauderdale, Florida 33308
970
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Fort Myers, Florida 33912
924
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Franklin, Tennessee 37064
348
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Gainesville, Florida 32607
713
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Garden City, New York 11530
496
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Gold River, California 95670
2030
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Greenbrae, California 94904
2109
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Gulf Shores, Alabama 36542
721
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Harleysville, Pennsylvania 19438
403
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Hawaiian Gardens, California 90716
1969
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Hialeah, Florida
987
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Hickory, North Carolina 28601
306
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Houston, Texas
991
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Huntington Beach, California 92647
1969
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Huntsville, Alabama 35801
411
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Jackson, Tennessee 38305
436
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Jacksonville, Florida
669
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Kalamazoo, Michigan
208
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Kissimmee, Florida 34741
810
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La Crosse, Wisconsin 54601
498
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Lake Charles, Louisiana
884
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Lake Worth, Florida 33461
937
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Lauderdale Lakes, Florida 33319
967
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Lexington, North Carolina 27292
323
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Little Rock, Arkansas
623
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Lomita, California 90171
1982
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Long Beach, California
1977
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Los Angeles, California
1972
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McAllen, Texas 78503
1291
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Metairie, Louisiana 70006
798
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Miami, Florida
994
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Mishawaka, Indiana 46544
201
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Mooresville, North Carolina
325
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Morganton, North Carolina 28655
300
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Nashville, Tennessee
332
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New Orleans, Louisiana 70112
797
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New Tazewell, Tennessee 37825
245
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Norco, California 92860
1938
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North Hollywood, California
1975
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Northglenn, Colorado 80234
1160
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Norwalk, California 90650
1967
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Oklahoma City, Oklahoma
849
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Omaha, Nebraska
685
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Orlando, Florida
795
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Oxnard, California 93030
2017
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Oxon Hill, Maryland 20745
331
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Palos Verdes, California 90274
?
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Paramount, California 90723
1972
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Pembroke Pines, Florida 33026
978
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Pharr, Texas 78577
1290
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Phoenix, Arizona
1662
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Plano, Texas
896
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Rapid City, South Dakota 57702
1072
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Rialto, California
1924
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Salt Lake City, Utah
1513
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San Angelo, Texas 76904
1136
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San Antonio, Texas
1138
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San Diego, California 92119
1951
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San Marino, California 91108
1963
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San Ramon, California 94582
2084
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Sandy Springs, Georgia 30328
424
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Scottdale, Pennsylvania 15683
182
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Smithfield, Pennsylvania 15478
170
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Smyrna, Tennessee 37167
400
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