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    Summary
    EudraCT Number:2020-002245-42
    Sponsor's Protocol Code Number:UP-CLI-2019-002
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-08-21
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-002245-42
    A.3Full title of the trial
    A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction
    Étude comparative de phase III randomisée, en double aveugle, 3 bras parallèles, visant à évaluer l’efficacité et la sécurité d’emploi d’une combinaison fixe de néfopam/paracétamol (comprimé) pris par voie orale dans la douleur modérée à sévère après l’extraction d’une troisième molaire incluse.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction
    Étude comparative de phase III randomisée, en double aveugle, 3 bras parallèles, visant à évaluer l’efficacité et la sécurité d’emploi d’une combinaison fixe de néfopam/paracétamol (comprimé) pris par voie orale dans la douleur modérée à sévère après l’extraction d’une troisième molaire incluse.
    A.3.2Name or abbreviated title of the trial where available
    METAPAIN
    A.4.1Sponsor's protocol code numberUP-CLI-2019-002
    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 SponsorUNITHER Pharmaceuticals
    B.1.3.4CountryFrance
    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 supportUNITHER Pharmaceuticals
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNITHER Pharmaceuticals
    B.5.2Functional name of contact pointNathalie MASSON
    B.5.3 Address:
    B.5.3.1Street Address3-5 Rue Saint-Georges
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75009
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0) 1 84 82 56 08
    B.5.5Fax number+33(0) 6 74 53 96 76
    B.5.6E-mailnathalie.masson@unither-pharma.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.3.1Product name30 mg nefopam hydrochloride / 500 mg paracetamol
    D.3.2Product code FDC 08P1737F0
    D.3.4Pharmaceutical form 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 INNNEFOPAM HYDROCHLORIDE
    D.3.9.1CAS number 23327-57-3
    D.3.9.3Other descriptive nameNEFOPAM HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03400MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPARACETAMOL
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Acupan
    D.2.1.1.2Name of the Marketing Authorisation holderMylan EPD bvba/sprl
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 namenefopam hydrochloride
    D.3.4Pharmaceutical form 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 INNNefopam hydrochloride
    D.3.9.1CAS number 23327-57-3
    D.3.9.3Other descriptive nameNEFOPAM HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03400MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 3
    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 Panadol
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare s.a./n.v.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameParacetamol
    D.3.4Pharmaceutical form 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 INNPARACETAMOL
    D.3.9.3Other descriptive namePANADOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic short-term treatment of moderate to severe somatic pain
    Traitement symptomatique à court terme de la douleur somatique modérée à sévère
    E.1.1.1Medical condition in easily understood language
    Tooth pain post surgery
    douleur dentaire après chirurgie
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10033371
    E.1.2Term Pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    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, after one single administration, the efficacy of nefopam hydrochloride (30 mg) / paracetamol (500 mg) x2 oral Fixed Dose Combination (FDC) versus oral nefopam hydrochloride alone (30 mg) x2 and oral paracetamol alone (500 mg) x2 in patients with moderate to severe pain after impacted third mandibular molar extraction.
    Évaluer, après une administration unique, l'efficacité du chlorhydrate de néfopam (30 mg) /paracétamol (500 mg) x2 en association à dose fixe (FDC) par voie orale par rapport au chlorhydrate de néfopam seul (30 mg) x2 administré par voie orale et le paracétamol seul (500 mg) x2 administré par voie orale chez des patients présentant une douleur modérée à sévère après l’ extraction d’une troisième molaire mandibulaire incluse.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of nefopam hydrochloride (30 mg) / paracetamol (500 mg) x2 oral Fixed Dose Combination (FDC) versus oral nefopam hydrochloride alone (30 mg) x2 and oral paracetamol alone (500 mg) x2 after single or multiple administrations.
    Evaluation de l'efficacité du chlorhydrate de néfopam (30 mg) / paracétamol (500 mg) x2 administré par voie orale en association à dose fixe par rapport au chlorhydrate de néfopam seul (30 mg) x2 administré par voie orale et au paracétamol seul (500mg) x2 administré par voie orale après des doses uniques ou multiples
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patient aged from 18 years up to 65 years at the time of signing the informed consent,
    2. Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,
    3. Patient weighing > 50 kg,
    4. Female patient of childbearing potential must be willing to use an efficient birth control method during the study,
    5. Patient able to swallow the IMP (capsule length 19.05 mm and width 9.39 mm),
    6. Patient able to understand and comply with protocol requirements and instructions, including recording of verbal rating scale (VRS) on the electronic diary (e-Diary) as required by protocol,
    7. Patient covered by national healthcare insurance system or similar system, if applicable by local regulations,
    8. Patient who has signed a written informed consent prior to any study-related procedures.
    1. Patient homme ou femme âgé(e) de 18 à 65 ans au moment de la signature du consentement éclairé,
    2. Patient(e) ayant programmé une extraction chirurgicale d’au moins une troisième molaire mandibulaire complètement ou partiellement incluse nécessitant une élimination de tissu osseux sous anesthésie locale à courte durée d'action (mépivacaïne ou lidocaïne) avec ou sans vasoconstricteur,
    3. Poids du/de la patient(e) > 50 kg,
    4. Les femmes en âge de d’avoir des enfants doivent accepter d’utiliser une méthode de contraception efficace au cours de l’étude,
    5. Le/la patient(e) est en mesure d’avaler le médicament expérimental (la gélule mesure 19,05 mm de long et 9,39 mm de large),
    6. Le/la patient(e) est capable de comprendre et de respecter les exigences et les instructions du protocole, notamment l la réalisation de l'échelle d'évaluation verbale (EEV) sur le journal électronique (e-Diary) comme requis par le protocole,
    7. Le/la patient(e) est couvert(e) par le système national d’assurance santé (Sécurité Sociale)
    8. Le/la patient(e) a signé un consentement éclairé écrit avant toute procédure liée à l’étude.
    E.4Principal exclusion criteria
    1. Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,
    2. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
    3. Patient with a history of convulsive disorders,
    4. Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),
    5. Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
    6. Patient with known anaemia,
    7. Patient with known pulmonary disease,
    8. Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
    9. Patient with known glaucoma,
    10. Patients with a prostatic hyperplasia or urinary retention,
    11. Patient with any known hypersensitivity to nefopam, paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP),
    12. Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
    13. Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
    14. Patient having developed hypersensitivity reactions, including symptoms of asthma, rhinitis or urticaria after taking acetylsalicylic acid or other NSAIDs,
    15. Patient with known systemic lupus erythematosus,
    16. Patient with drug or alcohol abuse within 6 months before dosing with study medication,
    17. Patient having participated in any clinical research study within the previous 30 days or 5 half-lives duration of the biological effect of the investigational product (whichever is longer),
    18. Patient having any current dental or medical condition that could prevent safe participation in this study,
    19. Unwillingness or inability to follow the procedures outlined in the protocol.
    1. Patient(e) ayant été traité(e) par des analgésiques ou des médicaments anti-inflammatoires non stéroïdiens (AINS) dans les 3 jours précédant la date de randomisation ou dans un délai de 5 fois la demi-vie d’élimination, selon la durée la plus longue,
    2. Femme présentant des résultats positifs à un test urinaire de grossesse, ou femme allaitante, ou femme en âge d‘avoir des enfants sans contraception efficace,
    3. Patient(e) ayant des antécédents de troubles convulsifs,
    4. Patient(e) prenant des inhibiteurs de mono-amine-oxydase (IMAO) (notamment, mais sans toutefois s’y limiter : sélégiline, isocarboxazide, tranylcypromine, phénelzine…),
    5. Patient(e) présentant une anomalie cardiaque : troubles de la fréquence ou du rythme cardiaque médicalement significatifs,
    6. Patient(e) ayant une anémie connue,
    7. Patient(e) ayant une maladie pulmonaire connue,
    8. Patient(e) ayant un ulcère gastrique ou duodénal actif ou des antécédents d’ulcères/de saignements gastro-intestinaux récurrents,
    9. Patient(e) ayant un glaucome connu,
    10. Patient(e)s présentant une hyperplasie de la prostate ou une rétention urinaire,
    11. Patient(e) ayant une hypersensibilité connue, quelle qu’elle soit, au néfopam, au paracétamol, à l’ibuprofène ou à des ingrédients contenus dans les médicaments expérimentaux ou dans le médicament non expérimental (MNE),
    12. Patient(e) ayant des antécédents actuels ou chroniques de maladie hépatique ou des anomalies hépatiques ou biliaires connues,
    13. Patient(e) ayant des antécédents actuels ou chroniques d’insuffisance rénale sévère (débit de filtration glomérulaire inférieur à 30 mL/min),
    14. Patient(e) ayant développé des réactions d’hypersensibilité, notamment des symptômes d’asthme, de rhinite ou d’urticaire après avoir pris de l’acide acétylsalicylique ou d’autres AINS,
    15. Patient(e) ayant un lupus érythémateux systémique connu,
    16. Patient(e) ayant présenté une toxicomanie ou de l’alcoolisme dans les 6 mois précédant l’administration du médicament à l’étude,
    17. Patient(e) ayant participé à une étude de recherche clinique dans les 30 jours précédents, ou au cours d’une période égale à 5 fois la demi-vie de la durée de l’effet biologique du produit expérimental (selon la durée la plus longue),
    18. Patient(e) présentant une affection dentaire ou médicale actuelle de tout type, susceptible de mettre en cause sa participation en toute sécurité à cette étude,
    19. Refus ou incapacité de suivre les procédures décrites dans le protocole.
    E.5 End points
    E.5.1Primary end point(s)
    Sum of Pain Intensity Differences at 6 hours (SPID0-6h) following the first IMP intake.
    Somme des différences d’intensité de la douleur à 6 heures (SPID0-6h) après la première prise de médicament expérimental.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PID will be calculated using the score of pain intensity assessed by the patient at defined time points (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min,) after the first IMP intake and/or right before first intake of rescue medication using a 100-mm VAS compared to baseline.
    La PID [différence d'intensité de la douleur] sera calculée d’après le score d’intensité de la douleur évalué par le/la patient(e) à des points temporels définis (T30, T45, T60, T90, T120, T150, T180, T240, T300, T360 min) après la première prise de médicament expérimental et/ou juste avant la première prise de médicament de secours à l’aide d’une échelle EVA de 100 mm en comparaison avec la valeur de référence.
    E.5.2Secondary end point(s)
    - Total Pain Relief,
    - Number and proportion of responder patients,
    - The Patient’s Global Impression of Change (PGIC) questionnaire assessment,
    - The onset of pain relief,
    - Soulagement complet de la douleur
    - Nombre et proportion de patients répondeurs
    - Questionnaire sur l’impression globale de changement par le/la patient(e)
    - Début du soulagement de la douleur
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Total Pain Relief: at 6 hours (TOTPAR0-6h) following the first IMP intake,
    - Number and proportion of responder patients: at 6 hours following the first IMP intake,
    - The Patient's Global Impression of Change (PGIC) questionnaire assessment: at 6 hours after the first IMP intake or at time of first intake of rescue medication,
    - The onset of pain relief: during the first 6 hours after the first IMP intake
    - Soulagement complet de la douleur: après la première prise de médicament expérimental.
    - Nombre et proportion de patients répondeurs: après la première prise de médicament expérimental.
    - Questionnaire sur l'impression globale de changement par le/la patient(e): évalué à 6 heures après la première prise de médicament expérimental ou au moment de la première prise de médicament de secours
    - The onset of pain relief: during the first 6 hours after the first IMP intake.
    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 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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Belgium
    France
    Russian Federation
    United Kingdom
    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
    The end of the study corresponds to the last visit of the last patient included in the study.
    La fin de l'étude est définie comme la date de la derniere visite du dernier patient.
    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 days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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: 311
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 10
    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 state112
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 274
    F.4.2.2In the whole clinical trial 321
    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)
    The participants' treatment is left to the physician's discretion.
    Le traitement des participants est laissé à la discrétion de l'investigateur.
    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 Decision2020-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-10-20
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