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    Summary
    EudraCT Number:2016-001520-66
    Sponsor's Protocol Code Number:UC-0106/1607
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-06-06
    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 number2016-001520-66
    A.3Full title of the trial
    Efficacy and safety of fentanyl citrate in painful access induced during diagnostic or therapeutic examinations in cancer patients
    Efficacité et tolérance du citrate de fentanyl dans les accès douloureux induits lors des examens diagnostiques ou thérapeutiques chez des patients souffrant de cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    Non applicable
    A.3.2Name or abbreviated title of the trial where available
    SDS-02_FARADI
    A.4.1Sponsor's protocol code numberUC-0106/1607
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportLaboratoire Kiowakirin
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointValérie PLENCE, Project Manager
    B.5.3 Address:
    B.5.3.1Street Address101 RUE DE TOLBIAC
    B.5.3.2Town/ cityPARIS CEDEX 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)1.71.93.67.07
    B.5.5Fax number+33(0)1 85.34.33.80
    B.5.6E-mailv-plence@unicancer.fr
    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 PECFENT
    D.2.1.1.2Name of the Marketing Authorisation holderArchimedes Development Ltd
    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.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfentanyl
    D.3.9.1CAS number 990-73-8
    D.3.9.3Other descriptive nameFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    D.2.1.1.1Trade name Abstral
    D.2.1.1.2Name of the Marketing Authorisation holderKYOWA KIRIN LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Sublingual tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfentanyl
    D.3.9.1CAS number 990-73-8
    D.3.9.3Other descriptive nameFENTANYL CITRATE
    D.3.9.4EV Substance CodeSUB02129MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboSublingual tablet
    D.8.4Route of administration of the placeboTransdermal use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboNasal spray
    D.8.4Route of administration of the placeboIntranasal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cancer patient
    Patient suivi et/ou traité pour une maladie cancéreuse
    E.1.1.1Medical condition in easily understood language
    Cancer patient
    Patient atteint d'un cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    MAIN OBJECTIVE / PHASE II TEST:
    To evaluate the efficacy of fentanyl citrate (FAR) administration during painful access (AD) induced by the positional requirements of diagnostic or therapeutic examinations in a group of patients with cancer who do not meet the criteria of the marketing autorization for the prescription of the FAR:
    - patients with less than 60 mg prolonged-release morphine;
    - patients with morphine sustained release for less than 7 days;
    - or opioid-naive patients.
    MAIN OBJECTIVE / COHORT:
    To evaluate the efficacy of FAR administration in ADs induced in the group of patients with FAR prescription under the MA (Management of ADP, in patients already having opioid-dependent less than one equivalent of 60 mg / day of oral morphine) for chronic pain of cancerous origin and for at least one week).
    OBJECTIF PRINCIPAL / ESSAI PHASE II :
    Evaluer l’efficacité de l’administration d’une prise de citrate de fentanyl (FAR) lors d’accès douloureux (AD) induits par les exigences positionnelles d’examens diagnostiques ou thérapeutiques dans un groupe des patients atteints d’un cancer qui ne satisfont pas aux critères de l’AMM pour la prescription du FAR :
    - patients ayant moins de 60 mg de morphine à libération prolongée ;
    - ou patients ayant une morphine à libération prolongée depuis moins de 7 jours ;
    - ou patients naïfs d’opioïde.
    OBJECTIF PRINCIPAL / COHORTE :
    Evaluer l’efficacité de l’administration du FAR lors des AD induits dans le groupe des patients avec prescription du FAR dans le cadre de l’AMM (Prise en charge des ADP, chez des patients ayant déjà un traitement de fond par opioïde (au moins un équivalent de 60 mg/j de morphine orale) pour des douleurs chroniques d’origine cancéreuse et ce depuis au moins une semaine).
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVE (S) / TRIAL PHASE II AND COHORT:
    - Evaluate the tolerance of FAR administration during Painful Access induced by the positional requirements of diagnostic or therapeutic examinations.
    - Evaluate the effectiveness of FAR on pain.
    - Evaluate the effectiveness of FAR on anxiety.
    - Evaluate the percentage of relief and patient satisfaction associated with taking FAR.
    SECONDARY OBJECTIVE (S) / TRIAL PHASE II:
    - Describe the causes of failure of diagnostic or therapeutic examinations
    OBJECTIF(S) SECONDAIRE(S) / ESSAI PHASE II ET COHORTE :
    - Evaluer la tolérance de l’administration du FAR lors des Accès Douloureux induits par les exigences positionnelles d’examens diagnostiques ou thérapeutiques.
    - Evaluer l’efficacité du FAR sur la douleur.
    - Evaluer l’efficacité du FAR sur l’anxiété.
    - Evaluer le pourcentage de soulagement et la satisfaction du patient liée à la prise de FAR.
    OBJECTIF(S) SECONDAIRE(S) / ESSAI PHASE II :
    - Décrire les causes d’échec des examens diagnostiques ou thérapeutiques
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient over 18 years old;
    2. Patient followed and / or treated for a cancerous disease;
    3. Patient with pain related to his cancer (localization related to the primary tumor and / or metastases);
    4. Patient
    a. not treated with opioids (naive)
    b. or treated for less than 7 days with opioid extended-release therapy and / or less than 60 mg per day of oral morphine, or less than 30 mg per day of oral oxycodone, or less than mg per day of oral hydromorphone, or less than 25 μg per hour of transdermal fentanyl;
    5. Patient having to perform at least one of the following examinations for a period of between 20 and 45 minutes during which the patient will be asked not to move:
    at. Radiation therapy session * including tomotherapy (outpatient or inpatient),
    b. Dosimetric scanner (hospitalized patient),
    c. Positron Tomography ** (PET-CT and TEMP-CT) (inpatient);
    6. Affiliation to a social security scheme.
    * A patient who is scheduled to return to radiation therapy for multiple sessions will only be included once.
    ** phase of acquisition lying supine and strictly immobile in one of the cameras (TEMP OR TEP).
    INCLUSION / COHORT CRITERIA:
    Identical to the inclusion criteria of the test except
    4. Patient treated for cancer pain with long-acting opioid
    at. for more than 7 days,
    b. and 60 mg or more of morphine per day, or 30 mg or more of oxycodone per day, or 8 mg of hydromorphone or more per day, or 25 microgram / h of transdermal fentanyl or more;
    6. Patient who believes that he will not be able to lie down and thus make the diagnostic or therapeutic examination because of pain in this position,
    or
    Patient who, when lying supine, presents a Painful Access (Digital Scale EN> 5) corresponding to a metastatic localization or to the primary tumor,
    or
    Patient presenting a Painful Access (Digital Scale EN> 5) corresponding to a metastatic localization or to the primary tumor preventing it from continuing the diagnostic or therapeutic examination;
    7. Affiliation to a social security scheme.
    1. Patient de plus de 18 ans ;
    2. Patient suivi et/ou traité pour une maladie cancéreuse ;
    3. Patient présentant des douleurs en rapport avec son cancer (localisation en lien avec la tumeur primitive et/ou les métastases) ;
    4. Patient
    a. non traité par opioïdes (naïf)
    b. ou traité depuis moins de 7 jours par un traitement opioïde à libération prolongée et/ou par moins de 60 mg par jour de morphine par voie orale, ou par moins de 30 mg par jour d’oxycodone par voie orale, ou par moins de 8 mg par jour d’hydromorphone par voie orale, ou par moins de 25μg par heure de fentanyl transdermique ;
    5. Patient devant réaliser au moins un des examens suivants, pour une durée comprise entre 20 et 45 min pendant laquelle il sera demandé au patient de ne pas bouger :
    a. Séance de radiothérapie* y compris tomothérapie (patient ambulatoire ou hospitalisé),
    b. Scanner dosimétrique (patient hospitalisé),
    c. Tomographie à Positons** (TEP-TDM et TEMP-TDM) (patient hospitalisé) ;
    6. Affiliation à un régime de sécurité sociale.
    CRITERES D’INCLUSION / COHORTE :
    Identiques aux critères d’inclusion de l’essai sauf
    4. Patient traités pour leur douleur cancéreuse par un morphinique à libération prolongée
    a. depuis plus de 7 jours,
    b. et par 60 mg de morphine ou plus par jour, ou par 30 mg d’oxycodone ou plus par jour, ou par 8 mg d’hydromorphone ou plus par jour, ou par 25 microgr/h de fentanyl transdermique ou plus ;
    6. Patient qui estime qu’il ne pourra pas s’allonger et donc faire l’examen diagnostique ou thérapeutique du fait de douleur dans cette position,
    ou
    Patient qui, lorsqu’il est allongé en décubitus dorsal, présente un Accès Douloureux (Echelle Numérique EN >5) correspondant à une localisation métastatique ou à la tumeur primitive,
    ou
    Patient présentant un Accès Douloureux (Echelle Numérique EN >5) correspondant à une localisation métastatique ou à la tumeur primitive l’empêchant de poursuivre l’examen diagnostique ou thérapeutique ;
    7. Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    1. Patient with a contraindication to taking fentanyl acetate: Severe respiratory depression or severe obstructive pulmonary disease;
    2. Patient already included once in the protocol;
    3. Patient with a history of alcoholism or drug addiction;
    4. Patient with self-controlled analgesic pump (PCA) opioid IV or SC;
    5. Patient who does not communicate or does not understand the instructions in French;
    6. Patient deprived of liberty and of age who is the subject of a measure of legal protection or unable to express his consent;
    7. Pregnant patient, likely to be pregnant or breastfeeding.
    1. Patient présentant une contre-indication à la prise d’acétate de fentanyl : Dépression respiratoire sévère ou pathologies pulmonaires obstructives sévères ;
    2. Patient ayant déjà été inclus une fois dans le protocole ;
    3. Patient présentant des antécédents d’alcoolisme ou de toxicomanie ;
    4. Patient porteur d’une pompe d’analgésie autocontrôlée (PCA) d’opioïde IV ou SC ;
    5. Patient non communiquant ou ne comprenant pas les consignes en langue française ;
    6. Patient privé de liberté et majeur faisant l’objet d’une mesure de protection légale ou hors d’état d’exprimer son consentement ;
    7. Patiente enceinte, susceptible de l’être, ou en cours d’allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    Efficiency is defined by success of carrying out diagnostic or therapeutic examination. A patient will be considered successful if the total planned immobilization time is respected (PET CT, TEMP CT, Radiotherapy, Tomotherapy) or if the planned tracking phase is performed (dosimetric scanner).

    If a patient has multiple treatments and / or imagery, only the first will be selected for evaluation of the primary endpoint.
    The primary endpoint will be evaluated after a dose of Fentanyl or placebo.
    The primary endpoint will be assessed blinded to the treatment received (Fentanyl or placebo): the evaluator will not be aware of the treatment received.
    L’efficacité est définie par le succès de la réalisation de l’examen diagnostique ou thérapeutique. Un patient sera considéré en succès si la durée d’immobilisation totale prévue est respectée (TEP TDM, TEMP TDM, Radiothérapie, Tomothérapie) ou si la phase de repérage prévue est réalisée (scanner dosimétrique).

    Si un patient bénéficie de plusieurs traitements et/ou imagerie, seul le premier sera retenu pour l’évaluation du critère de jugement principal.
    Le critère principal sera évalué après l’administration d’une dose de Fentanyl ou placebo.
    Le critère de jugement principal sera évalué en insu du traitement reçu (Fentanyl ou placebo) : l’évaluateur n’aura pas connaissance du traitement reçu.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After successful or unsuccessful completion of the imaging analysis.
    A l'issue de l'examen d'imagerie, réalisé avec ou sans succès.
    E.5.2Secondary end point(s)
    - The tolerance will be evaluated according to the classification of the NCI-CTC toxicity scale v4.03.
    - The pain will be evaluated by numerical scale (EN), during the diagnostic or therapeutic examination.
    - Anxiety will be assessed by the Hospital Anxiety and Depression Scale (HAD).
    - Relief from pain before treatment is expressed by the patient on a scale of 0% (no relief) to 100% (maximum relief). An overall satisfaction score, related to taking FAR, between 0 (not at all satisfied) and 10 (very satisfied) is also indicated by the patient.
    - The causes of failure of the examination will be described according to the following modalities: Tolerance problem, Patient painful (not relieved) or Other cause, if failure after the second treatment.
    - Unblinded success, in the Phase II study only, will be evaluated by the following question asked to the patient within 30 minutes after the end of the diagnostic or therapeutic examination, whatever its outcome (complete or failed): " In which group do you think you have been randomized? ".
    - La tolérance sera évaluée selon la classification de l’échelle de toxicité NCI-CTC v4.03.
    - La douleur sera évaluée par échelle numérique (EN), au cours de l’examen diagnostique ou thérapeutique.
    - L’anxiété sera évaluée par l’échelle de dépression HAD (Hospital Anxiety and Depression Scale).
    - Le soulagement par rapport à la douleur avant prise du traitement est exprimé par le patient sur une échelle de 0% (pas de soulagement) à 100% (soulagement maximal). Une note globale de satisfaction, liée à la prise de FAR, entre 0 (pas du tout satisfait) et 10 (très satisfait) est également indiquée par le patient.
    - Les causes d’échec de l’examen seront décrites selon les modalités suivantes : Problème de tolérance, Patient douloureux (non soulagé) ou Autre cause, si échec après la seconde prise de traitement.
    - Le succès de l’insu, dans l’étude de phase II uniquement, sera évalué par la question suivante posée au patient dans les 30 minutes après la fin de l’examen diagnostique ou thérapeutique quelquesoit son issu (complet ou échec) : « Dans quel groupe pensez-vous avoir été randomisé ? ».
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The assessment of tolerance will be made from the first treatment until 4 hours after the last treatment.
    - The pain will be assessed during the examination at the following time: T0 (first dose of FAR treatment or Placebo), T5 (T0 + 5min), T10 (T0 + 10min), T15 (T0 + 15 min), T30 ( T0 + 30min), T60 T0 + 60min).
    - The anxiety will be evaluated within 30 minutes after the end of the diagnostic or therapeutic examination.
    - Relief from pain is expressed within 30 minutes after the end of the diagnostic or therapeutic examination.
    - The causes of failure of the exam will be described if failure after the second treatment take.
    - Blind Success, in the Phase II study only, will be evaluated within 30 minutes after completion of the examination.
    - L’évaluation de la tolérance sera faite depuis la première prise de traitement jusqu’à 4 heures après la dernière prise de traitement.
    - La douleur sera évaluée au cours de l’examen au temps suivant : T0 (Première prise du traitement FAR ou Placebo), T5 (T0+5min), T10 (T0+10min), T15 (T0+15 min), T30 (T0+30min), T60 T0+60min).
    - L’anxiété sera évaluée dans les 30 minutes après la fin de l’examen diagnostique ou thérapeutique.
    - Le soulagement par rapport à la douleur est exprimée dans les 30 minutes après la fin de l’examen diagnostique ou thérapeutique.
    - Les causes d’échec de l’examen seront décrites si échec après la seconde prise de traitement.
    - Le succès de l’insu, dans l’étude de phase II uniquement, sera évalué dans les 30 minutes après la fin de l’examen.
    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 No
    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 Yes
    E.8.1.4Double blind No
    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) No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned15
    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 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 years
    E.8.9.1In the Member State concerned months24
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 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 state180
    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)
    Not applicable
    Non applicable
    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 Decision2017-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-13
    P. End of Trial
    P.End of Trial StatusOngoing
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