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    Summary
    EudraCT Number:2019-002283-27
    Sponsor's Protocol Code Number:1812VA323
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-13
    Trial 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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2019-002283-27
    A.3Full title of the trial
    A phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-selection study of S-600918 in patients with refractory chronic cough
    Multicentrické, randomizované, dvojitě zaslepené, placebem kontrolované klinické hodnocení fáze 2, s paralelními skupinami, k výběru dávky přípravku S-600918 u pacientů s refrakterním chronickým kašlem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research study of an investigational drug called S-600918 for refractory chronic cough, defined as chronic cough that continues after treatment for the disease(s) causing the cough or as unexplained chronic cough for which the disease has not been determined.
    A.4.1Sponsor's protocol code number1812VA323
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04110054
    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 B.V.
    B.1.3.4CountryNetherlands
    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 & Co., Ltd
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShionogi B.V.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address33 Kingsway
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 6UF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442030534200
    B.5.5Fax number+442030534199
    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.3.2Product code S-600918
    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 established
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeS-600918
    D.3.9.3Other descriptive nameS-600918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 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
    Refractory chronic cough
    E.1.1.1Medical condition in easily understood language
    Chronic cough which continues without enough improvement after treatment for the disease(s) causing the cough, or as an unexplained cough, for which the disease has not been determined.
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066656
    E.1.2Term Chronic cough
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with placebo
    E.2.2Secondary objectives of the trial
    To compare the efficacy of S-600918 to that of placebo in patients with refractory chronic cough based on the following measurements:
    - Number of coughs per hour while awake
    - Number of coughs per hour while asleep
    - Severity of cough as assessed on the Visual Analog Scale (VAS)
    - Leicester Cough Questionnaire (LCQ)
    - International Consultation on Incontinence Modular Questionnaire-Short Form (ICIQ SF)
    - Short-Form (36) Health Survey (SF-36), version 2
    - Patient Global Impression of Change (PGIC)
    To evaluate the safety of S-600918 in patients with refractory chronic cough.
    To assess the pharmacokinetics (PK) of S-600918 and its metabolite (S-600918 acyl glucuronide) in patients with refractory chronic cough.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female outpatient ≥18 to ≤80 years of age at the time of signing the informed consent form.
    -Has refractory chronic cough lasting for at least 1 year prior to Visit 1, defined as: insufficient improvement in cough after treatment for the underlying condition(s) causing the cough OR unexplained cough for which an underlying condition has not been determined
    -With severity of cough assessed as ≥40 mm on the Visual Analog Scale (VAS) at both Visit 1 and Visit 2.
    -With cough count ≥10 times per hour based on the 24- hour cough count recording at Visit 1. (Results will be available by Visit 2; no calculation is necessary).
    -If female, agreement to use one of the following contraceptive methods from screening until 14 days after the last dose of study drug UNLESS the patient is surgically sterile by hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy or tubal ligation with appropriate documentation of such surgery or postmenopausal (defined as at least 12 months of spontaneous amenorrhea in women >45 years of age).
    Progestogen-only oral hormonal contraception (where inhibition of ovulation is not the primary mode of action), male or female condom with or without spermicide, cap, diaphragm, or sponge with spermicide.
    E.4Principal exclusion criteria
    - Currently smokes or uses potentially irritating inhalational agents (eg,
    e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using
    potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
    - Has chronic obstructive pulmonary disease (COPD) or, as defined in the Global Initiative for Asthma (GINA) 2019, has uncontrolled asthma symptoms (excluding cough).
    - Has a clinically unstable medical condition.
    - History of or ongoing significant psychiatric disorder.
    - History of respiratory tract infection or significant change in lung
    function or a pulmonary condition in the last 4 weeks.
    - History of malignancy in the last 5 years.
    - History of severe drug allergy.
    - History of alcohol or drug abuse in the last year or currently uses any
    form of marijuana or illicit drugs.
    - With any finding on a chest x-ray or chest CT scan (performed not more than 1 year prior to Visit 1 after onset of chronic cough at Visit 1) that could be considered the cause of chronic cough or indicative of lung disease. (If a chest x- ray or chest CT scan needs to be performed, results will be available by Visit 2.) (Note: Patients with abnormal chest image findings not considered to be the cause of chronic cough are eligible to participate.)
    - Has systolic blood pressure > 160 mm Hg or diastolic blood pressure >
    90 mm Hg.
    - Received S-600918 previously.
    - Received an investigational drug in the last 3 months.
    - Received an angiotensin converting enzyme (ACE) inhibitor in the last
    3 months or requires such treatment.
    - Has a positive serologic test for human immunodeficiency virus (HIV)
    antigen or antibody, hepatitis B virus surface antigen, or hepatitis C
    virus ribonucleic acid (RNA).
    - If female, pregnant or trying to become pregnant or breastfeeding.

    COVID-19 related Measure is provided in Protocol Version 3.1 page no.
    36 (Exclusion Criteria, Point no. 19)
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the ratio of the number of coughs per hour in 24 hours (based on cough counts recorded by the cough monitor) after administration of study drug for 4 weeks to that at baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4
    E.5.2Secondary end point(s)
    •A reduction from baseline in the number of coughs per hour in 24 hours by ≥30%, ≥50%, and ≥70%
    • The ratio of the number of coughs per hour while awake after administration of study drug for 4 weeks to that at baseline and a reduction by ≥30%, ≥50%, and ≥70%
    • The ratio of the number of coughs per hour while asleep after administration of study drug for 4 weeks to that at baseline
    • The change from baseline in weekly cough severity as assessed on the VAS (electronic tablet)
    • The change from baseline through Day 7 in daily cough severity as assessed on the VAS (eDiary)
    • The change in LCQ and achievement of an increase (ie, improvement) of ≥1.3 points
    • The change in ICIQ-SF
    • The change in SF-36
    • PGIC
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    Czech Republic
    Japan
    Poland
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 372
    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 Decision2020-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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