None listed
Conditions
Interventions
PATIENTS WHO SIGN AN INFORMED CONSENT AND MEET ALL OF THE INCLUSION CRITERIA AND NONE OF THE EXCLUSION CRITERIA WILL BE ENROLLED INTO THE STUDY.
ENROLLED PATIENTS WILL BE RANDOMLY ASSIGNED TO 1 OF
Sponsors
Toyama Chemical Co., Ltd.,
Eligibility
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT HAS PROVIDED WRITTEN INFORMED CONSENT PRIOR TO PERFORMING ANY STUDY-RELATED PROCEDURES. 2. MALE OR FEMALE PATIENTS 20-80 YEARS OLD, INCLUSIVE. 3. PATIENTS WHO TEST POSITIVE FOR INFLUENZA A OR B BY A COMMERCIALLY AVAILABLE RAPID ANTIGEN TEST (RAT) OF THE NASOPHARYNX. A PATIENT WITH A NEGATIVE RAT RESULT MAY STIL ENROLL IF THE SPONSOR AND INVESTIGATOR AGREE THAT THERE IS A KNOWN INFLUENZA OUTBREAK CIRCULATING IN THE COMMUNITY. 4. PATIENTS ≥ 20 BUT < 65 YEARS OLD WITH A TEMPERATURE (ORAL) OF 100.4°F (38.0°C) OR MORE; PATIENTS ≥ 65 YEARS OLD WITH A TEMPERATURE (ORAL) 100.0°F (37.8°C) OR MORE AT THE FIRST VISIT, OR IN THE 6 HOURS PRIOR IF ANTIPYRETICS WERE TAKEN. 5. MALE PATIENTS MUST AGREE TO THE FOLLOWING: • THEY ARE INCAPABLE OF FATHERING A CHILD (HAVE HAD A VASECTOMY AT LEAST 6 MONTHS AGO AND HAVE HAD SPERM COUNTS VERIFYING THAT THEY ARE NO LONGER FERTILE) OR • THEY DO NOT INTEND TO FATHER A CHILD WITHIN 3 MONTHS AFTER THE LAST DOSE OF THE STUDY DRUG, IN WHICH CASE: . THEY MUST USE A CONDOMS DURING SEXUAL INTERCOURSE WITH A FEMALE PARTNER WHO COULD BECOME PREGNANT OR THEY MUST ABSTAIN FROM SEXUAL INTERCOURSE.
Exclusion criteria
Exclusion criteria: 1. FEMALE PATIENTS WHO ARE PREGNANT, BREAST-FEEDING, OR HAVE A POSITIVE URINE PREGNANCY TEST AT VISIT 1. 2. PATIENTS WHO HAVE HAD INFLUENZA SYMPTOMS OR FEVER (ie., ONE OF THE SYMPTOMS LISTED UNDER THE INCLUSION CRITERIA) FOR 36 HOURS OR MORE PRIOR TO STUDY SCREENING. 3. PATIENTS WHO HAVE TAKEN A ANTI-INFLUENZA DRUG (eg., AMANTADINE HYDROCHLORIDE, RIMANTADINE, OSELTAMIVIR PHOSPHATE, ZANAMIVIR HYDRATE OR PERAMIVIR) OR LIVE VACCINATION WITHIN 4 WEEKS PRIOR TO THE BEGINNING OF THE STUDY. 4. PATIENTS WHO HAVE UNDERLYING CHRONIC RESPIRATORY DISEASE (eg., COPD, CHRONIC BRONCHITIS, DIFUSE PARBRONCHIOLITIS, BRONCHIECTASIS, PULMONARY EMPHYSEMA, PULMONARY FIBROSIS, BRONCHIAL ASTHMA, OR OLD TUBERCULOSIS). 5. PATIENTS WHO AT THE BEGINNING OF THE STUDY ARE SUSPECTED OF HAVING BACTERIAL RESPIRATORY INFECTION (ie., EXPECTORATION OF PURULENT OR MUCOPURULENT SPUTUM AND/OR INFILTRATE IN LUNG IN A CHEST X-RAY, ETC.). 6. PATIENTS WHO HAVE A HISTORY OF GOOT ARE UNDER TRATMENT FOR GOUT OR HYPERURICEMIA. 7. PATIENTS WITH HEREDITARY XANTHINURIA. 8. PATIENTS WHO HAVE A HISTORY OF HYPOURICEMIA (UNDER 1 mg/dL) OR XANTHINE CALCULI OF THE URINARY TRACT.
Countries
Australia, Chile, New Zealand, Paraguar, South Africa, United States
Contacts
Public ContactAzalea Saldaña
INC Research Peru S.A.C
Outcome results
None listed