Submitted by: Analyn Gumafelix 2017-06-22 00:00:00 Last Updated by: Analyn Gumafelix 2018-05-28 11:38:27 Export to PDF

Study of S-033188 Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications (CAPSTONE 2)

PHRR170720-001577

1602T0832

CTR 2017-CT0397

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
2017-07-31 12 2018-07-31 2018-07-13

Completed

Institution Classification Region LTO #
RPS Research Philippines, Inc. Private Business NCR CDRR-NCR-CRO-15
Institution Classification Region LTO #
Shionogi & Co., Ltd. Private Business Japan
Institution Amount Region
Shionogi & Co., Ltd. N/A Japan
Name E-Mail 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 E-Mail Phone Number Postal Address
Melissa Mitchener Melissa.mitchener@shionogi.com 973-830-7909 Shionogi Inc. 300 Campus Drive Florham Park, NJ 07932
Name Expertise Affiliation
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

Influenza

  • 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%).

Unspecified

Completed

  • Australia
  • Belgium
  • Bulgaria
  • Germany
  • Hungary
  • Japan
  • Latvia
  • New Zealand
  • Philippines
  • Poland
  • Romania
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom
  • United States

Clinical Trial

Unspecified

2017-05-31

None

Inclusion Criteria:

  1. 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.
  2. Male or female patients ≥ 12 years at the time of signing the informed consent/assent form.
  3. Patients with a duration of influenza symptoms confirmed by all of the following:

    1. Fever ≥ 38ºC (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
    2. 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)

  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 1 new general or respiratory symptom
  5. 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
  6. Patients will be considered at high risk* of influenza complications due to the presence of at least 1 of the following inclusion criteria:

    1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
    2. Endocrine disorders (including diabetes mellitus)
    3. Residents of long-term care facilities (eg, nursing homes)
    4. 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)
    5. 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)
    6. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
    7. Adults aged ≥ 65 years
    8. American Indians and Alaskan Natives
    9. Blood disorders (such as sickle cell disease)
    10. Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
    11. Morbid obesity (body mass index ≥ 40)
    12. Women who are within 2 weeks postpartum and are not breastfeeding

Exclusion Criteria:

  1. Patients with severe influenza virus infection requiring inpatient treatment.
  2. Patients with known allergy to oseltamivir (Tamiflu®).
  3. Patients unable to swallow tablets or capsules.
  4. Patients who have previously received S-033188.
  5. Patients weighing ≤ 40 kg.
  6. Patients who have been exposed to an investigational drug within 30 days prior to the predose examinations.
  7. 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:

    1. Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test)
    2. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
  8. Patients with concurrent infections at the predose examinations requiring systemic antimicrobial therapy.
  9. Patients with liver disease associated with hepatic impairment.
  10. Patients with cancer within the last 5 years (unless nonmelanoma skin cancer).
  11. Patients with untreated HIV infection or treated HIV infection with a CD4 count below 350 cells/mm3 in the last 6 months.
  12. Patients with immunosuppression following organ or bone marrow transplants.
  13. Patients exceeding 20 mg of prednisolone or equivalent dose of chronic systemic corticosteroids.
  14. Patients who have received peramivir, laninamivir, oseltamivir, zanamivir, rimantadine, umifenovir or amantadine within 30 days prior to the predose examinations.
  15. Patients who have received an investigational monoclonal antibody for a viral disease in the last year.
  16. Patients with known creatinine clearance ≤ 60 mL/min.
  17. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Interventional

Experimental: S-033188; Active Comparator: Oseltamivir; Placebo Comparator: Placebo

Experimental: S-033188
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.

Randomized

Double Blind

Unspecified

Parallel

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.

Phase III

32

17

Due to low flu season and enrollment ended earlier than planned.

31 Jul 2017

Utilization Utilization Info
No records found.

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