Study of S-033188 Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE 2)
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 Patients with Influenza at High Risk of Influenza Complications
This is a randomized, double-blind, multicenter, parallel-group, placebo- and active controlled study enrolling approximately 2157 patients diagnosed with influenza randomly assigned in a 1:1:1 ratio to receive a single, oral dose of S-033188, oseltamivir 75 mg BID for 5 days, or placebo. Patients who weigh < 80 kg at Screening will receive 40 mg of S-033188, and patients who weigh ≥ 80 kg at Screening will receive 80 mg of S-033188.
|Start Date||Duration in Months||Target Completion Date||Actual Completion Date|
|RPS Research Philippines, Inc.||Private Business||NCR||CDRR-NCR-CRO-15|
|Shionogi & Co., Ltd.||Private Business||Japan|
|Shionogi & Co., Ltd.||N/A||Japan|
|Name||Phone Number||Postal Address|
|Leslie P. Catolos||CatolosLeslie@prahs.com||+63-9178317537||RPS Research Philippines, Inc., Unit 4050, 40th Floor, Regus, PB Com Makati, 6795 Ayala Avenue corner Rufino, 1226 Makati City, Philippines|
|Name||Phone Number||Postal Address|
|Melissa Mitchener||Melissa.email@example.com||973-830-7909||Shionogi Inc. 300 Campus Drive Florham Park, NJ 07932|
|Ronald Allan R. Payumo, MD||Pulmonologist||Mary Johnston Hospital|
|Tito C. Atienza, MD||Pulmonologist||Veterans Memorial Medical Center|
|Camilo C. Roa Jr., MD||Pulmonologist||Medical Center Manila|
|Arnold Germar, MD||Pulmonologist||The Medical City|
|Benjamin P. Sablan, Jr., MD||Pediatrician||Philippine General Hospital|
|Ma. Bella R. Siasoco, MD||Pulmonologist||St. Luke's Medical Center - Quezon City|
|Project Location||Institutional Ethics Review Board|
|Mary Johnston Hospital||Mary Johnston Hospital Ethics & Review Committee|
|Veterans Memorial Medical Center||Veterans Memorial Medical Center Ethics Review Committee|
|Medical Center Manila||Manila Medical Ethics Review Committee|
|The Medical City||The Medical City - Institutional Review Board|
|Philippine General Hospital||Philippine General Hospital Ethics Review Board|
|St. Luke's Medical Center - Quezon City||St. Luke's Medical Center Institutional Ethics Review Committee|
- Time to improvement of symptoms [Time Frame: From Day 1 pretreatment up to Day 14]
- Time to improvement of symptoms is defined as the time from initiation of study treatment to improvement of influenza symptoms for a duration of at least 21.5 hours (24 hours - 10%).
- New Zealand
- South Africa
- South Korea
- United Kingdom
- United States
- Patients or their legal guardians who provide written informed consent to participate in the study on a voluntary basis. For adolescent patients, informed consent/assent of voluntary participation should be obtained in accordance with local requirements.
- Male or female patients ≥ 12 years at the time of signing the informed consent/assent form.
Patients with a duration of influenza symptoms confirmed by all of the following:
- Fever ≥ 38ºC (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
- At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater:
i. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) ii. Respiratory symptoms (cough, sore throat, or nasal congestion)
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:
- Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature)
- Time when the patient experiences at least 1 new general or respiratory symptom
- If a women of childbearing potential, agrees to use a highly effective method of contraception for 3 months after the first dose of study drug
Patients will be considered at high risk* of influenza complications due to the presence of at least 1 of the following inclusion criteria:
- Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
- Endocrine disorders (including diabetes mellitus)
- Residents of long-term care facilities (eg, nursing homes)
- Compromised immune system (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a CD4 count > 350 cells/mm³ within the last 6 months)
- Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, eg, cerebral palsy, epilepsy [seizure disorders], stroke, muscular dystrophy, or spinal cord injury)
- Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
- Adults aged ≥ 65 years
- American Indians and Alaskan Natives
- Blood disorders (such as sickle cell disease)
- Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
- Morbid obesity (body mass index ≥ 40)
- Women who are within 2 weeks postpartum and are not breastfeeding
- Patients with severe influenza virus infection requiring inpatient treatment.
- Patients with known allergy to oseltamivir (Tamiflu®).
- Patients unable to swallow tablets or capsules.
- Patients who have previously received S-033188.
- Patients weighing ≤ 40 kg.
- Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations.
Women who are pregnant, breastfeeding, or have a positive pregnancy test at the predose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test at the predose examinations:
- Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test)
- Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
- Patients with concurrent infections at the predose examinations requiring systemic antimicrobial therapy.
- Patients with liver disease associated with hepatic impairment.
- Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).
- Patients with untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months.
- Patients with immunosuppression following organ or bone marrow transplants.
- Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic corticosteroids.
- Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to the predose examinations.
- Patients who have received an investigational monoclonal antibody for a viral disease in the last year.
- Patients with known creatinine clearance ≤ 60 mL/min.
- Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions
Experimental: S-033188; Active Comparator: Oseltamivir; Placebo Comparator: Placebo
Participants aged ≥ 12 years to 64 years will receive two or four 20-mg S 033188 tablets orally on Day 1 and one oseltamivir placebo capsule orally twice a day (BID) on Days 1 to 5.
Active Comparator: Oseltamivir
Participants aged ≥ 12 years to 64 years will receive 75 mg oseltamivir twice a day on Days 1 to 5 and two or four S 033188 placebo tablets on Day 1.
Placebo Comparator: Placebo
Participants aged ≥ 12 years to 64 years will receive two or four S 033188 placebo tablets on Day 1 and one oseltamivir placebo capsule orally twice a day on Days 1 to 5.
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 improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.
Due to low flu season and enrollment ended earlier than planned.
31 Jul 2017
|No records found.|