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    Summary
    EudraCT Number:2017-005160-18
    Sponsor's Protocol Code Number:RP101-200
    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:2018-09-11
    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 number2017-005160-18
    A.3Full title of the trial
    A Phase II, multicentre, randomised, placebo-controlled, double-masked trial of RP101 ophthalmic formulation versus vehicle in post-menopausal women with moderate to severe dry eye syndrome
    Eine multizentrische, randomisierte, Placebo-kontrollierte, doppelt maskierte Phase II Studie der ophtalmologischen Suspension RP101 im Vergleich zu Vehikel bei postmenopausalen Frauen mit moderatem bis schwerem Syndrom des trockenen Auges
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of the ophtalmic formulation RP101 versus placebo in post-menopausal women with moderate to severe dry eye syndrome
    Eine Studie über die Augentropfen RP101 im Vergleich zu Placebo bei Patientinnen in der Postmenopause mit moderatem bis schwerem Syndrom des trockenen Auges
    A.3.2Name or abbreviated title of the trial where available
    RP101 Phase II dry eye syndrom
    RP101 Phase II Sicca-Syndrom
    A.4.1Sponsor's protocol code numberRP101-200
    A.5.4Other Identifiers
    Name:CRO code numberNumber:CRO-17-132
    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 SponsorRedwood Pharma AB
    B.1.3.4CountrySweden
    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 supportRedwood Pharma AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROSS Research S.A.
    B.5.2Functional name of contact pointClinical Project Unit
    B.5.3 Address:
    B.5.3.1Street AddressVia F.A. Giorgioli 14
    B.5.3.2Town/ cityArzo
    B.5.3.3Post code6864
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number004191630 05 10
    B.5.5Fax number0041 91630 05 11
    B.5.6E-mailprojectmanagement@croalliance.com
    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 RP101 0.05%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNto be considered
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeE3P
    D.3.9.3Other descriptive name17β-estradiol-3-phosphate
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    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 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 RP101 0.1%
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNto be considered
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeE3P
    D.3.9.3Other descriptive name17β-estradiol-3-phosphate
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 placeboEye drops, solution
    D.8.4Route of administration of the placeboOcular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe dry eye syndrome
    Moderates bis schweres Syndrom des trockenen Auges
    E.1.1.1Medical condition in easily understood language
    Moderate to severe dry eye syndrome
    Moderates bis schweres Syndrom des trockenen Auges
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10013774
    E.1.2Term Dry eye
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to establish the effective dose/dose regimen of RP101 in post-menopausal women with moderate to severe dry eye syndrome applying RP101 ophthalmic sterile solution or matching placebo (vehicle) once (q.d.) or twice a day (b.i.d.) for 3 months.
    Das primäre Ziel der Studie ist die Bestimmung der wirksamen Dosis/Dosierungsschemata von RP101 bei Frauen in der Postmenopause mit mittelschwerem bis schwerem Sicca-Syndrom bei der Verabreichung von sterilen RP101 Augentropfen oder dem entsprechenden Placebo (Trägersubstanz) einmal täglich (q.d.) oder zweimal täglich (b.i.d.) über 3 Monate.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - to evaluate the safety and tolerability of the treatment
    - to evaluate as exploratory variables tear film osmolarity and corneal pachymetry in specific substudies
    - to evaluate the pharmacokinetics (PK) of serum 17-β-oestradiol after the 1st and the last dose (only PK substudy)
    Die sekundären Ziele der Studie sind:
    - Evaluierung der Sicherheit und Verträglichkeit der Behandlung
    - Evaluierung der Osmolarität des Tränenfilms und der Hornhaut-Pachymetrie als Prüfvariablen in spezifischen Substudien
    - Evaluierung der Pharmakokinetik (PK) des Serum-17-β-Estradiols nach der ersten und letzten Dosis (PK-Substudie)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The pharmacokinetik sub-study is included in the main study protocol (Final version 2.0, 07Dec18). The objective is to evaluate the pharmacokinetics (PK) of serum 17-β-oestradiol after the 1st and the last dose of RP101. Up to 50 out of the 100 planned patients will take part in this sub-study.
    Die Pharmakokinetik-Substudie im Studienprotokol (Final version 2.0, 07Dec18) enthalten. Ziel ist die Beurteilung der Pharmakokinetik (PK) des Serum-17-β-Estradiols nach der ersten und letzten Dosis des RP101. Bis zu 50 der geplanten 100 Patientinnen werden an dieser Substudie teilnehmen.
    E.3Principal inclusion criteria
    1. Informed consent: signed written informed consent before inclusion in the study
    2. Sex and menopause: postmenopausal women; postmenopausal condition defined as final menstrual period at least 3 years before the screening
    3. Dry eye syndrome: patients with moderate to severe dry eye syndrome
    4. Schirmer’s test type II: Schirmer’s test with anaesthesia ≤ 7 mm/5 min in the worse eye (study eye)
    5. Fluorescein: corneal fluorescein staining score ≥ 2.0 in one or more regions of the worse eye (study eye) and ≤ 10 in total across all 5 corneal regions according to the NEI scale
    6. Tear film breakup time: TFBUT ≤ 10 sec in the worse eye (study eye)
    7. Visual acuity: corrected visual acuity ≥ 20/200 in each eye
    8. Symptoms: at least 2 of the typical dry eye syndrome symptoms since at least 3 months before the screening: foreign body sensation, burning/stinging, redness, tearing, pain, itching, blurred vision, photophobia, eyelid swelling, moisture and mucous discharge
    9. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
    1. Informierte Einwilligung: Unterzeichnete Einverständniserklärung vor Aufnahme in die Studie nach einem Einwilligungsgespräch
    2. Geschlecht und Menopause: Frauen in der Postmenopause; Postmenopause heißt, dass die letzte Menstruation mindestens 3 Jahre vor der Screening-Visite zurückliegt
    3. Sicca-Syndrom: Patientinnen mit mittelschwerem bis schwerem Sicca-Syndrom
    4. Schirmer-II-Test: Schirmer-Test mit Anästhesie ≤7 mm/5 min im stärker betroffenen Auge (Studienauge)
    5. Fluorescein: Ein Wert ≥ 2,0 bei der Hornhautfärbung mit Fluorescein in einer oder mehreren Regionen des stärker betroffenen Auges (Studienauge) und ≤ 10 in insgesamt allen 5 Hornhautregionen gemäß NEI-Skala
    6. Tränenfilmaufrisszeit (Tear film breakup time, TFBUT): TFBUT ≤10 sec im stärker betroffenen Auge (Studienauge)
    7. Sehschärfe: korrigierte Sehschärfe ≥20/200 in jedem Auge
    8. Symptome: Mindestens 2 der typischen Symptome des Sicca-Syndroms seit mindestens 3 Monaten vor der Screening Visite: Fremdkörpergefühl, Brennen/Stechen, Rötung, Tränen, Schmerzen, Jucken, verschwommene Sicht, Lichtempfindlichkeit, Lidschwellung, Feuchtigkeits- und Schleimabsonderungen
    9. Umfassendes Verständnis: Fähigkeit, die Art und den Zweck der Studie, einschließlich der möglichen Risiken und Nebenwirkungen in vollem Umfang zu verstehen; Fähigkeit, mit dem Prüfer zusammenzuarbeiten und die Anforderungen der Studie zu erfüllen
    E.4Principal exclusion criteria
    1. Hysterectomy: women younger than 55 with partial or complete hysterectomy
    2. Meibomian gland dysfunction: severe Meibomian gland dysfunction defined as lid deformity, marked lid margin hyperaemia or severe Meibomian gland loss
    3. Ophthalmic treatment: current use of topical ophthalmic medications other than ocular lubricants or artificial tears within 30 days before the screening
    4. Ocular infection and inflammation: presence of any bacterial or viral or fungal infection in either eye or active inflammation not related to dry eye disease (i.e. follicular conjunctivitis, iris or preauricular adenopathy) in either eye
    5. Ophthalmic diseases: severe forms of ophthalmic surface diseases e.g. ocular pemphigoid, Sjögren’s disease, exposure keratitis
    6. Ophthalmic surgery: history of ophthalmic surgery or trauma in the last 6 months; history of laser-assisted in situ keratomileusis (LASIK) in the previous 12 months
    7. Intraocular pressure: intraocular pressure >21 mmHg
    8. Contact lenses: use of therapeutic or refractive contact lenses in either eye within 30 days of study enrolment
    9. Concomitant treatments: topical cyclosporine; topical corticosteroids or any other topical medication for the treatment of dry eye in either eye within 30 days before the screening; systemic medications admitted only if at a stable dose for at least 3 months before the screening; systemic or topical hormonal therapies within 3 months before the screening
    10. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or ingredients of investigational product or Oculotect® or rescue medication; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
    11. Diseases: uncontrolled systemic diseases including cardiovascular, pulmonary and/or renal diseases, diabetes, hypertension; history of ovarian, breast or uterine cancer or unexplained vaginal bleeding
    12. Investigative drug studies: participation in the evaluation of any investigational product or medical device for 30 days before this study
    1. Hysterektomie: Frauen unter 55 Jahren mit teilweiser oder kompletter Hysterektomie
    2. Meibom-Drüsen-Dysfunktion: Schwere Meibom-Drüsen-Dysfunktion definiert als Lidveränderungen, ausgeprägte Rötung der Lidränder oder schwerer Meibom-Drüsen-Verlust
    3. Ophthalmische Behandlung: Laufende Anwendung von topischen Augenarzneimitteln, ausgenommen Benetzungstropfen oder künstliche Tränen, innerhalb von 30 Tagen vor der Screening Visite
    4. Augeninfektionen und Augenentzündungen: Bakterielle, Virus- oder Pilzinfektionen in einem Auge oder aktive Entzündungen, die nicht im Zusammenhang mit dem Sicca-Syndrom stehen (wie z. B. follikuläre Konjunktivitis, Iris- oder präaurikuläre Lymphadenopathie) in einem Auge
    5. Augenerkrankungen: Schwere Formen einer Erkrankung der Augenoberfläche, wie okuläres Pemphigoid, Sjögren-Syndrom, Expositionskeratitis
    6. Operationen am Auge: Vorausgegangene Augenoperation oder Augenverletzung in den letzten 6 Monaten; vorausgegangene Laser-in-situ-Keratomileusis (LASIK) in den letzten 12 Monaten
    7. Augeninnendruck: intraokularer Druck >21 mmHg
    8. Kontaktlinsen: Anwendung therapeutischer oder refraktärer Kontaktlinsen in einem Auge innerhalb von 30 Tagen vor Aufnahme in die Studie
    9. Begleittherapien: Topisches Ciclosporin; topische Kortikosteroide oder andere topische Arzneimittel zur Behandlung des Sicca-Syndroms an einem Auge innerhalb von 30 Tagen vor der Screening Visite; systemische Behandlungen sind nur zulässig, wenn sie mit gleichbleibender Dosis mindestens 3 Monate vor der Screening Visite durchgeführt wurden; systemische oder topische Hormontherapien innerhalb von 3 Monaten vor der Screening Visite
    10. Allergien: Gesicherte oder vermutete Überempfindlichkeit gegenüber dem Wirkstoff und/oder den sonstigen Bestandteilen des Prüfpräparats, von Oculotect® oder der Rescue-Medikation vorausgegangene Anaphylaxie nach der Anwendung von Arzneimitteln oder allergische Reaktionen allgemein, die nach dem Ermessen des Prüfers die Studienergebnisse beeinträchtigen könnten
    11. Erkrankungen: Nicht behandelte systemische Erkrankungen, einschließlich kardiovaskulärer, Lungen- und/oder Nierenerkrankungen, Diabetes, Hypertonie; vorausgegangene Krebserkrankung der Eierstöcke, Brust oder unerklärliche vaginale Blutungen
    12. Klinische Medikamenten-Studie: Teilnahme an einer Untersuchung von Prüfpräparaten oder Medizinprodukten in einem Zeitraum von 30 Tagen vor dieser Studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the evaluation of the clinical efficacy during and at the end of the treatment with RP101 ophthalmic sterile solution or matching placebo (vehicle) on the basis of Schirmer test II (with anaesthesia).
    Primärer Endpunkt ist die Beurteilung der klinischen Wirksamkeit während und am Ende der Behandlung mit sterilen RP101 Augentropfen oder dem entsprechenden Placebo (Trägersubstanz) anhand des Schirmer-II-Tests (mit Anästhesie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months or last timepoint of patient data collection (in case of early discontinuation).
    3 Monate oder der letzte Zeitpunkt der Datenerhebung des Patienten (im Falle eines frühzeitigen Abbruchs).
    E.5.2Secondary end point(s)
    Evaluation of the clinical efficacy and safety during and at the end of treatment with RP101 ophthalmic sterile solution or matching placebo (vehicle), on the basis of the following parameters:
    - Visual analogue scale (VAS) for ocular tolerability (foreign body sensation, burning/stinging, itching, pain,sticky feeling, blurred vision, redness, tearing, eyelid swelling and photophobia)
    - Symptom Assessment in Dry Eye (SANDE)
    - Visual acuity (early treatment diabetic retinopathy study [ETDRS] chart)
    - Slit lamp examination
    - Tear film osmolarity(only specific substudy)
    - Tear film breakup time (TFBUT)
    - Fundus ophthalmoscopy
    - Corneal fluorescein staining
    - Corneal pachymetry(only specific substudy)
    - Frequency of instillation (i.e.number of drops instilled daily)of artificial tears (rescue medication) during the treatment phase
    Secondary safety and tolerability endpoints:
    - Intraocular pressure (IOP)
    - Treatment-emergent adverse events (TEAEs), assessed throughout the study
    - Clinical laboratory assays including haematology, blood chemistry and endocrinology
    - Vital signs (blood pressure, pulse rate), body weight,physical examinations
    Secondary PK endpoints:
    - Evaluation of the PK of serum 17-β-oestradiol(only PK substudy): 17-β-oestradiol serum concentrations, Cmax, Tmaxand AUC0-t
    Evaluierung der klinischen Wirksamkeit und Sicherheit während und am Ende der Behandlung mit sterilen RP101 Augentropfen oder dem entsprechenden Placebo (Trägersubstanz) anhand der folgenden Parameter:
    - Visuelle Analogskala (VAS) für die Beurteilung der okularen Erträglichkeit (Fremdkörpergefühl, Brennen/Stechen, Jucken,Schmerzen, klebriges Gefühl im Auge, verschwommene Sicht, Rötung, Tränen, Lidschwellung undLichtempfindlichkeit)
    - Erfassung der Symptome des Sicca-Syndroms (SANDE, Symptom Assessment iN Dry Eye)
    - Sehschärfe (gemäß ETDRS-Skala aus der „Early Treatment Diabetic Retinopathy Study“)
    - Spaltlampen-Untersuchung
    - Osmolarität des Tränenfilms (nur spezifische Substudie)
    - Tränenfilmaufrisszeit
    - Funduskopie
    - Hornhautfärbung mit Fluorescein
    - Hornhautpachymetrie (nur spezifische Substudie)
    - Instillationshäufigkeit (d. h. tägliche Tropfenzahl) der künstlichen Tränen (Rescue-Medikation) während der Behandlungsphase
    Sekundäre Sicherheits-und Verträglichkeits-Endpunkte:
    - Intraokularer Druck (IOD)
    - Therapiebedingte unerwünschte Ereignisse Erfassung während der gesamten Studie
    - Laborchemische Untersuchungen, einschließlich Hämatologie, Blutchemie und Endokrinologie
    - Vitalzeichen(Blutdruck, Pulsfrequenz), Körpergewicht, körperliche Untersuchungen
    Sekundäre PK-Endpunkte:
    - Evaluierung der PK des Serum-17-β-Estradiols (nur PK-Substudie): 17-β-Estradiol-Serumkonzentrationen, Cmax, Tmaxund AUC0-t
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months or last timepoint of patient data collection (in case of early discontinuation).
    3 Monate oder der letzte Zeitpunkt der Datenerhebung des Patienten (im Falle eines frühzeitigen Abbruchs).
    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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 100
    F.4.2.2In the whole clinical trial 100
    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 Decision2019-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-18
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