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    Summary
    EudraCT Number:2016-002426-37
    Sponsor's Protocol Code Number:EA-16-01-077
    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:2016-08-08
    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 ConcernedGermany - BfArM
    A.2EudraCT number2016-002426-37
    A.3Full title of the trial
    Randomized, placebo-controlled, double-blind, multi-center trial to evaluate the efficacy and safety of 2 Prospan® posologies (2x 7.5 mL/day and 3x 5 mL/day) in the treatment of acute bronchitis
    Randomisierte, Placebo- kontrollierte, doppelblinde, multizentrische Studie zur Bewertung der Wirksamkeit und Sicherheit der Anwendung zweier Prospan® Dosierungen (2x 7,5 ml/Tag und 3x 5 ml/Tag) in der Behandlung von akuter Bronchitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to evaluate the efficacy and safety of 2 Prospan® posologies (2x 7.5 ml and 3x 5 ml) vs. Placebo in the treatment of acute bronchitis
    Studie zur Bewertung der Wirksamkeit und Sicherheit zweier Prospan®
    Dosierungen gegenüber Placebo in der Behandlung von akuter Bronchitis
    A.4.1Sponsor's protocol code numberEA-16-01-077
    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 SponsorEngelhard Arzneimittel GmbH & Co.KG
    B.1.3.4CountryGermany
    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 supportEngelhard Arzneimittel GmbH & Co.KG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinsearch GmbH
    B.5.2Functional name of contact pointProf. Dr. Dr. Bruno Giannetti
    B.5.3 Address:
    B.5.3.1Street AddressChamerstrasse 172
    B.5.3.2Town/ cityZug
    B.5.3.3Post code6300
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number00491722763628
    B.5.6E-mailinfo@clinsearch.ch
    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 Yes
    D.2.1.1.1Trade name Prospan Hustenliquid
    D.2.1.1.2Name of the Marketing Authorisation holderEngelhard Arzneimittel GmbH & Co.KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameProspan Hustenliquid
    D.3.4Pharmaceutical form Oral liquid
    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 INNIvy leaves Cough Liquid
    D.3.9.3Other descriptive nameIVY LEAVES, DRY EXTRACT
    D.3.9.4EV Substance CodeSUB26939
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboOral liquid
    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
    Acute bronchitis
    Akute Bronchitis
    E.1.1.1Medical condition in easily understood language
    Acute bronchitis
    Akute Bronchitis
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000687
    E.1.2Term Acute bronchitis
    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
    The objective of this study is to evaluate the efficacy and safety of two
    different doses of ivy leaves cough liquid with placebo in the treatment
    of acute bronchitis. The primary variable is the assessment of severity of
    bronchitis using BSS (Bronchitis Severity Score)
    Primäres Ziel: Die Bewertung der Wirksamkeit und Unbedenklichkeit
    zweier Hustenliquids mit Efeublätter-Trockenextrakt Dosierung im
    Vergleich zu Placebo bei Patienten mit akuter Bronchitis. Die primäre
    Variable ist die Bewertung des Schweregrads der Bronchitis mit Hilfe des
    BSS (Bronchitis Severity Score)
    E.2.2Secondary objectives of the trial
    - Difference of the BSS assessed over the whole observation period
    - Difference of the BSS between V1 and V5 with regard to ivy leaves
    cough liquid vs. placebo each in the dosage 3x5ml
    - Difference of the BSS between V1 and V5 with regard to ivy leaves
    cough liquid vs. placebo each in the dosage 2x7,5ml
    - Difference of the BSS between V1 and V5 with regard to verum applied
    3x5ml vs. verum applied 2x7,5ml daily
    - Difference of the CS assessed on Visual Analogue Scale (VAS) over the
    whole observation period
    - Difference of the CS assessed by the Verbal Category Descriptive Score
    (VCD) over the whole observation period
    - Change of spirometrical values (FEV1, FVC, FEV1/FVC%) between V1
    and each of the visits V2, V5 and V6
    - Global efficacy and tolerability assessment at V5 and V6
    - Safety of ivy leaves cough liquid compared with placebo over the whole
    treatment period
    - Unterschiede bei der BSS bewertet über den gesamten
    Beobachtungszeitraum
    - Unterschiede bei der BSS zwischen V1 und V5 in Bezug auf Efeublätter-Hustenliquid gegen Placebo in der Einzeldosierung 3x5ml
    - Unterschiede bei der BSS zwischen V1 und V5 in Bezug auf Efeublätter-
    Hustenliquid gegen Placebo in der Einzeldosierung 2x7.5ml
    - Unterschiede bei der BSS zwischen V1 und V5 in Bezug zwischen den
    Verum Einzeldosierungen 3x5ml und 2x7.5ml täglich
    - Unterschiede in der CS bewertet mit der Visuellen Analogskala (VAS)
    über den gesamten Beobachtungszeitraum
    - Unterschiede in der CS bewertet durch den Verbal Category Descriptive
    Score (VCD) über den gesamten Beobachtungszeitraum
    - Veränderungen spirometrischer Messwerte (FEV1, FVC, FEV1/FVC%)
    zwischen V1 und den einzelnen Visiten V2, V5 und V6
    - Globale Wirksamkeit und Verträglichkeit bewertet zum Zeitpunkt V5
    und V6
    - Sicherheit des Efeublätter-Hustenliquids verglichen mit Placebo über
    dem gesamten Behandlungszeitraum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Acute bronchitis with symptoms lasting 48 to 72 hours prior to treatment
    2) Men or women of any ethnic origin
    3) Age 18 to 75 years
    4) Subjects who are able to understand and are willing to comply to trial instructions
    5) Having given written informed consent
    6) Satisfactory health except for the bronchitis as determined by the investigator based on medical history and physical examination
    7) CS score of at least 50 mm on a 100 mm VAS at V1
    8) BSS of at least 10 points at V1
    9) VCD score of at least 2 points at V1
    1) Akute Bronchitis mit Symptomen, die seit 48 bis 72 Stunden vor der Behandlung bestehen
    2) Männliche oder weibliche Patienten jeglichen ethnischen Ursprungs
    3) Alter 18 bis 75 Jahre
    4) Patienten, die in der Lage sind, die Studienvorschriften zu verstehen und Willens sind, diese zu befolgen
    5) Patienten, die eine schriftliche Einwilligung zur Studie abgegeben haben
    6) Mit Ausnahme der vorhandenen Bronchitis ansonsten zufriedenstellender Gesundheitszustand basierend auf der Anamnese und der körperlichen Untersuchung
    7) CS Wert von mindestens 50 mm auf der 100 mm VAS bei V1
    8) ein BSS von mindestens 10 Punkten bei V1
    9) ein VCD Wert von mindestens 2 Punkten bei V1
    E.4Principal exclusion criteria
    1) Allergic bronchial asthma, bronchial hyperreactivity, chronic bronchitis, other chronic or inherited lung disease
    2) History of hypersensitivity to any excipient of the applied drugs
    3) History of drug hypersensitivity, asthma, urticaria, or other severe allergic diathesis as well as current hay fever
    4) History of chronic gastritis or peptic ulcers
    5) Any gastrointestinal complaints within 7 days before V1
    6) Participation in a clinical trial within 30 days prior to the treatment phase of this study or concomitantly
    7) Treatment with corticoids, beta-2 agonists (e.g. salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g. aspirin) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, angiotensin-converting enzyme (ACE) inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate or homeopathic drugs against common cold within 7 days before V1
    8) Drug or alcohol abuse in the opinion of the investigator
    9) Pregnant or nursing (lactating) women
    10) Body temperature >38.3°C
    11) Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) who are not using an acceptable method of contraception defined as:
    • Surgical sterilization
    • Hormonal contraception
    • Intra-Uterine Device (IUD)
    • Double barrier method
    • Total abstinence throughout the trial at the discretion of the investigator
    Periodic abstinence is NOT an acceptable method of contraception. An acceptable method of contraception must be maintained throughout the trial.
    A woman who is post-menopausal must have a negative urine pregnancy test at screening but will not need to comply with an acceptable method of contraception. Women are considered post-menopausal and not of child-bearing potential if they had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    12) Subjects with significant diseases, defined as a disease which, in the opinion of the investigator, may either put the subject at risk because of participation in the trial or a disease which may influence the results of the trial or the subject’s ability to participate in the trial; includes subjects with a history of gastrointestinal bleeding, significant cardiovascular, liver or renal disease.
    13) Subjects directly or indirectly involved in the execution of this protocol, including employees of the CRO and persons related to them.
    1) Allergisches bronchiales Asthma, Bronchienhyperreagibilität, chronische Bronchitis, andere chronische oder erbliche Lungenerkrankungen
    2) Anamnese von Überempfindlichkeit gegenüber einem der Bestandteile der angewendeten Medikamente
    3) Anamnese von Arzneimittelüberempfindlichkeit, Asthma, Urtikaria oder andere schwerwiegende allergische Diathesen sowie aktuell Heuschnupfen
    4) Anamnese von chronischer Gastritis oder peptischem Ulcus
    5) Jegliche gastrointestinalen Beschwerden innerhalb der letzten 7 Tage vor Visite1
    6) Teilnahme an einer klinischen Prüfung innerhalb der letzten 30 Tage vor der Behandlungsphase in dieser Studie
    7) Behandlung mit Korticoiden, Beta-2 Agonisten (z.B. Salbutamol, Fenoterol), Expektorantien, Theophyllin, Antitussiva, Anästhetika, Acetylsalicylsäure (z.B. Aspirin) oder anderen nicht-steroidalen anti- inflammatorischen Arzneimitteln, Leukotrien-Inhibitoren, ACE-Hemmern, antiviralen Arzneimitteln oder Antibiotika, Antihistaminika, Immunsuppressiva, Isoprenaline, Atropin, Natrium Cromoglycat oder homöopathischen Arzneimitteln gegen Erkältung innerhalb der letzten 7 Tagen vor Visite 1
    8) Medikamenten- oder Alkoholabusus laut Meinung des Prüfers
    9) Schwangere oder stillende Frauen
    10) Körpertemperatur >38.3°C
    11) Gebärfähige Frauen (das heißt alle Frauen, die physiologisch in der Lage sind, schwanger zu werden), die keine akzeptable Verhütungsmethode anwenden, definiert wie folgt:
    a. Chirurgische Sterilisation
    b.Hormonelle Kontrazeption
    c.Intrauterinpessar (IUD)
    d.Doppelte Barrieremethode
    e.Völlige Abstinenz während der gesamten Studiendauer nach Ermessen des PrüfersPeriodische Abstinenz ist als kontrazeptive Methode nicht akzeptabel. Eine akzeptable Verhütungsmethode muss über die gesamte Studiendauer beibehalten werden.
    Frauen in der post-Menopause müssen einen negativen Urinschwangerschaftstest beim Einschluss aufweisen, müssen aber nicht eine der o.g. akzeptablen kontrazeptiven Methoden anwenden. Frauen werden als in der post-Menopause eingestuft und als nicht mehr gebärfähig, wenn sie in den letzten 12 Monaten eine natürliche (spontane) Amenorrhoe mit entsprechendem klinischen Profil (z.B. passendes Alter, Anamnese von vasomotorischen Symptomen) oder sechs Monate spontane Amenorrhoe mit Serum FSH Werten >40mIU/mL aufweisen, oder wenn sie sich einer chirurgischen bilateralen Oophorektomie (mit oder ohne Hysterektomie) mindestens sechs Wochen vor der Studie unterzogen haben. Falls nur eine Oophorektomie durchgeführt wurde, muss die fehlende Gebärfähigkeit der Frau durch Bestimmung der Hormonspiegel bestätigt werden
    12) Patienten, die an einer signifikanten Erkrankung leiden, definiert als eine Erkrankung, die im Ermessen des Prüfers entweder den Patienten durch die Teilnahme an der Studie einem Risiko aussetzt, oder die die Ergebnisse der Studie oder die Fähigkeit des Patienten, an der Studie teilzunehmen, beeinträchtigt; schließt Patienten mit einer Anamnese von gastrointestinalen Blutungen, signifikanten kardiovaskulären, hepatischen oder renalen Erkrankungen ein
    13) Patienten, die direkt oder indirekt an der Durchführung dieser Studie beteiligt sind, einschließlich Mitarbeiter der CRO und deren Verwandte
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy outcome is the change of CS assessed by the
    Bronchitis Severity Score (BSS) between V1 and V5 with regard to
    pooled vera vs. pooled placebo.
    Die primäre Variable ist die Bewertung des Schweregrads der Bronchitis
    mit Hilfe des BSS (Bronchitis Severity Score)) zwischen Visite 1 und
    Visite 5
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 days, V1 and V5
    2 Tage, V1 und V5
    E.5.2Secondary end point(s)
    1. Difference of the BSS assessed over the whole observation period
    (between V1 and each of the visits V2, V3, V4, V5 and V6)
    2. Difference of the BSS between V1 and V5 with regard to ivy leaves
    cough liquid vs. placebo each in the dosage 3x5 mL
    3. Difference of the BSS between V1 and V5 with regard to ivy leaves
    cough liquid vs. placebo each in the dosage 2x7.5 mL
    4. Difference of the BSS between V1 and V5 with regard to verum
    applied 3x5 mL vs. verum applied 2x7.5 mL daily
    5. CS assessed on Visual Analogue Scale (VAS) over the whole
    treatment period (area under the curve (AUC) over 7 days, V1 V2, V3, V4
    and V5)
    6. Difference of the CS assessed by the Verbal Category Descriptive
    Score (VCD) over the whole observation period (between V1 and each of
    the visits V2, V3, V4, V5 and V6)
    7. Change of spirometrical values (FEV1, FVC, FEV1/FVC%) between V1
    and each of the visits V2, V5 and V6
    8. Global efficacy and tolerability assessment at V5 and V6
    9. Safety of ivy leaves cough liquid compared with placebo over the
    whole treatment period (7 days, V1, V2, V3, V4 and V5).
    1. Unterschiede bei der BSS bewertet über den gesamten
    Beobachtungszeitraum (zwischen V1 und den einzelnen Visiten V2, V3,
    V4, V5 und V6)
    2. Unterschiede bei der BSS zwischen V1 und V5 in Bezug auf
    Efeublätter-Hustenliquid gegen Placebo in der Einzeldosierung 3x5ml
    3. Unterschiede bei der BSS zwischen V1 und V5 in Bezug auf
    Efeublätter-Hustenliquid gegen Placebo in der Einzeldosierung 2x7.5ml
    4. Unterschiede bei der BSS zwischen V1 und V5 in Bezug
    zwischen den Verum Einzeldosierungen 3x5ml und 2x7.5ml täglich
    5. Unterschiede in der CS bewertet mit der Visuellen
    Analogskala (VAS) über den gesamten Behandlungsungszeitraum (zwischen V1 und den einzelnen Visiten V2, V3, V4 und V5)
    6. Unterschiede in der CS bewertet nach Verbalkategorien
    durch den Verbal Category Descriptive Score (VCD) über den gesamten
    Beobachtungszeitraum (zwischen V1 und den einzelnen Visiten V2, V3,
    V4, V5 und V6)
    7. Veränderungen spirometrischer Messwerte (FEV1, FVC,
    FEV1/FVC%) zwischen V1 und den einzelnen Visiten V2, V5 und V6
    8. Globale Wirksamkeit und Verträglichkeit bewertet zum
    Zeitpunkt V5 und V6
    9. Sicherheit des Efeublätter-Hustenliquids verglichen mit
    Placebo über dem gesamten Behandlungszeitraum (7 Tage, V1, V2, V3,
    V4 und V5)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 14 days: V1, V2, V3, V4, V5 and V6
    2. 2 days: V1 and V5
    3. 2 days: V1 and V5
    4. 2 days: V1 and V5
    5. 7 days: V1, V2, V3, V4 and V5
    6. 14 days: V1, V2, V3, V4, V5 and V6
    7. 4 days: V1, V2, V5 and V6
    8. 2 days: V5 and V6
    9. 7 days: V1, V2, V3, V4 and V5
    1. 14 Tage: V1, V2, V3, V4, V5 und V6
    2. 2 Tage: V1 und V5
    3. 2 Tage: V1 und V5
    4. 2 Tage: V1 und V5
    5. 7 Tage: V1, V2, V3, V4 und V5
    6. 14 Tage: V1, V2, V3, V4, V5 und V6
    7. 4 Tage: V1, V2, V5 und V6
    8. 2 days: V5 and V6
    9. 7 days: V1, V2, V3, V4 and V5
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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 concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Data base lock
    Datenbank geschlossen
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    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: 193
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state210
    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
    keine
    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 Decision2016-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-09-23
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