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    Summary
    EudraCT Number:2016-002688-32
    Sponsor's Protocol Code Number:1602T0832
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-002688-32
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial which compares the effectiveness and safety of a not yet approved drug, called S-033188, versus placebo, and versus an approved drug (Oseltamivir) for 5 Days in Patients with Influenza at High Risk of Influenza Complications
    A.4.1Sponsor's protocol code number1602T0832
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShionogi Ltd.
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShionogi Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi & Co. Ltd
    B.5.2Functional name of contact pointCorporate Communications Department
    B.5.3 Address:
    B.5.3.1Street Address1-8, Doshomachi 3-chome
    B.5.3.2Town/ cityChuo-ku, Osaka,
    B.5.3.3Post code541-0045
    B.5.3.4CountryJapan
    B.5.4Telephone number+8166209 7885
    B.5.6E-mailshionogiclintrials-admin@shionogi.co.jp
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameS-033188
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot yet assigned
    D.3.9.1CAS number 1830312-72-5
    D.3.9.2Current sponsor codeS-033188
    D.3.9.3Other descriptive nameS-033188
    D.3.9.4EV Substance CodeSUB182710
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tamiflu® Hard Capsules 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameoseltamivir
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOSELTAMIVIR
    D.3.9.1CAS number 196618-13-0
    D.3.9.4EV Substance CodeSUB03553MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Influenza
    E.1.1.1Medical condition in easily understood language
    Influenza
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10022005
    E.1.2Term Influenza viral infections
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022002
    E.1.2Term Influenza A virus infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10022003
    E.1.2Term Influenza B virus infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of a single, oral dose of S-033188 compared with oseltamivir 75 mg twice daily (BID) for 5 days by measuring the time to improvement of influenza symptoms in patients with influenza.
    • To evaluate the efficacy of a single, oral dose of S-033188 compared with placebo by measuring the secondary endpoints in patients with influenza.
    • To evaluate the efficacy of a single, oral dose of S-033188 compared with oseltamivir 75 mg BID for 5 days by measuring the secondary endpoints in patients with influenza.
    • To evaluate the polymorphic and treatment-emergent amino acid substitutions in the polymerase acidic protein (PA) gene and drug susceptibility in patients with evaluable virus.
    • To compare the safety and tolerability of a single dose of S-033188 with placebo.
    • To compare the safety and tolerability of a single dose of S-033188 with oseltamivir 75 mg BID for 5 days.
    •Further objectives are listed in the enclosed protocol.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who fulfill all of the following criteria will be included in the study:
    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 diagnosis of influenza confirmed by all of the following:
    a.Fever ≥ 38ºC (axillary) during the predose examinations or > 4 hours after dosing of antipyretics if they were taken
    b.At least 1 each of the following general and respiratory symptoms associated with influenza (excluding those that are chronic and existed in the 30 days prior to the influenza episode) 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 (Screening) is 48 hours or less. The onset of symptoms is defined as either:
    a.Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature)
    b.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 S 033188 or oseltamivir
    6.Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
    a.Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
    b.Endocrine disorders (including diabetes mellitus)
    c.Residents of long-term care facilities (eg, nursing homes)
    d.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)
    e.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)
    f.Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart related symptoms
    g.Adults aged ≥ 65 years
    h.American Indians and Alaskan Natives
    i.Blood disorders (such as sickle cell disease)
    j.Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
    k.Morbid obesity (body mass index ≥ 40)
    l.Women who are within 2 weeks postpartum and are not breastfeeding
    E.4Principal exclusion criteria
    Patients who meet any of the following criteria will be excluded from the study:
    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:
    a.Postmenopausal women (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test)
    b.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 an unknown CD4 count or 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 current creatinine clearance ≤ 60 mL/min (≤ 30 mL/min in Japan).
    17.Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose-galactose intolerance.
    18. Pediatric patients in countries where national legislation prohibits the conduct of studies with a placebo arm in pediatrics.
    19. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the time to improvement of influenza symptoms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout study duration
    E.5.2Secondary end point(s)
    ● Proportion of patients positive for virus titer and proportion of patients positive by RT-PCR at each time point
    ● Change from baseline in virus titer and in the amount of virus (RT-PCR) at each time point
    ● AUC adjusted by baseline in virus titer and in the amount of virus RNA (RT-PCR)
    ● Time to cessation of viral shedding by virus titer and by RT-PCR
    ● Proportion of patients whose symptoms has been alleviated at each time point
    ● Time to alleviation of symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue)
    ● Time to improvement in the 4 systemic symptoms (headache, feverishness/chills, muscle/joint pain, and fatigue)
    ● Time to improvement in the 3 respiratory symptoms (cough, nasal congestion,
    and sore throat)
    ● Time to resolution of fever
    ● Proportion of patients reporting normal temperature at each time point
    ● Body temperature at each time point
    ● Time to improvement of each influenza symptom
    ● Time to return to preinfluenza health status
    ● Requirement for systemic antibiotics for infections secondary to influenza infection
    ● Incidence of influenza-related complications (hospitalization, death, sinusitis, bronchitis, otitis media, and radiologically confirmed pneumonia).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout study duration
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Japan
    Korea, Republic of
    Latvia
    Moldova, Republic of
    New Zealand
    Philippines
    Poland
    Romania
    Singapore
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 431
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 431
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 863
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 863
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adolescents (12-17 years)
    Adolescents (12-17 years)
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    persons in nursing homes
    F.4 Planned number of subjects to be included
    F.4.1In the member state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 101
    F.4.2.2In the whole clinical trial 2157
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-20
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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