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    Summary
    EudraCT Number:2019-001274-29
    Sponsor's Protocol Code Number:CHUBX2017/46
    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:2019-06-03
    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 number2019-001274-29
    A.3Full title of the trial
    Evaluation of the efficacy of intra-nasal sufentanil for analgesia of vaso-occlusive crisis in sickle-cell adults -
    Evaluation de l’efficacité du sufentanil intra-nasal pour l’analgésie des crises vaso-occlusives de l’adulte drépanocytaire.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Analgesia with intranasal sufentanil in sickle-cell crisis.
    Analgésie avec sufentanil intranasal en crise drépanocytaire.
    A.3.2Name or abbreviated title of the trial where available
    DREPSUFINDOL
    DREPSUFINDOL
    A.4.1Sponsor's protocol code numberCHUBX2017/46
    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 SponsorCHU de Bordeaux
    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 supportDGOC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointCéline BAIRRAS-MARTIN
    B.5.3 Address:
    B.5.3.1Street Address12 rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.5Fax number556794926+33
    B.5.6E-mailceline.bairras-martin@chu-bordeaux.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 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 nameSufentanil IN
    D.3.4Pharmaceutical form Inhalation vapour, liquid
    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 INNSUFENTANIL
    D.3.9.1CAS number 56030-54-7
    D.3.9.4EV Substance CodeSUB10671MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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.2.5The 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMORPHINE
    D.3.9.1CAS number 57-27-2
    D.3.9.3Other descriptive nameMORPHINE
    D.3.9.4EV Substance CodeSUB03332MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.2.5The 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 Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNITROUS OXIDE
    D.3.9.1CAS number 10024-97-2
    D.3.9.3Other descriptive nameNITROUS OXIDE
    D.3.9.4EV Substance CodeSUB03447MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOXYGEN
    D.3.9.3Other descriptive nameOXYGEN
    D.3.9.4EV Substance CodeSUB14733MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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.2.1.2Country 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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMORPHINE
    D.3.9.1CAS number 57-27-2
    D.3.9.3Other descriptive nameMORPHINE
    D.3.9.4EV Substance CodeSUB03332MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Analgesia of vaso-occlusive crisis in sickle-cell adults
    L'analgésie des crises vaso-occlusives de l’adulte drépanocytaire
    E.1.1.1Medical condition in easily understood language
    Analgesia
    analgésie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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
    The aim of this study is to assess efficacy of intranasal sufentanil relayed by morphine IV, compared to usual protocol, Equimolar Mixture of Oxygen-Nitrous Oxide, relayed by morphine IV, in vaso-occlusive crisis in sickle cell disease.
    L'objectif de cet essai est de comparer l’efficacité des traitements sufentanil intra-nasal / morphine IV versus MEOPA / morphine IV à 30 minutes après le début du traitement chez des patients drépanocytaires atteints de crises vaso-occlusives.
    E.2.2Secondary objectives of the trial
    Compare between both treatment groups:
    • Side events occurring during management up to 4 hours after initiation of treatment
    • Proportion of patients relieved (NRS ≤ 3/10) 15, 60 and 120 minutes after starting treatment.
    • Morphine consumption (mg) 60 and 120 minutes after starting treatment.
    • Time (minutes) to obtain an effective analgesia
    • Time (minutes) to obtain a venous access
    Comparer entre les deux groupes de traitement :
    o la proportion d’effets indésirables 30 minutes, 2 heures et 4 heures après le début du traitement ;
    o la proportion de patients soulagés 15, 60 et 120 minutes après le début du traitement ;
    o la consommation de morphine 60 et 120 minutes après le début du traitement;
    o le délai d’obtention du soulagement ;
    o le délai de pose de la voie veineuse.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Age 18 to 75 years old;
    . Sickle-cell patient.
    . Signs of a vaso-occlusive crisis (migratory bone pain, which may occur in the limbs, spine, thorax, pelvis, skull) or crisis known as such by the patient;
    . Severe pain (NRS ≥ 6/10) on admission to the ED;
    - Age de 18 à 75 ans ;
    - Patient drépanocytaire;
    - Présentant des signes de crise vaso-occlusive : douleurs osseuses migratrices, pouvant siéger au niveau des membres, du rachis, du thorax, du bassin, du crâne, ou crise connue comme telle par le patient;
    - Douleur d’intensité sévère (EN ≥ 6/10) lors de l’admission aux urgences.
    E.4Principal exclusion criteria
    - Strong opioids received in the previous 6 hours;
    - Pregnancy or breastfeeding;
    - Oxygen saturation below 93%;
    - Patients who cannot cooperate because of a State of agitation or a Cognitive impairment
    - Unable to do self-assessment;
    - Allergy or intolerance to opiates or nitrous oxide.
    - Abuse or addiction to opioids
    - Liver insufficiency
    - Renal insufficiency
    - Severe asthma or chronic obstructive bronchopulmonary disease
    - Pulmonary disease necessitating oxygen
    - Presence of seriousness signs:
    • All respiratory seriousness signs
    • all neurologic signs or consciousness impairment (coma Glasgow scale under 15)
    • hyperthermia over than 39°C
    • Signs of intolerance of acute anemia
    • Signs of hemodynamic failure
    • Known organ failure (renal insufficiency, pulmonary high blood pressure)
    • A description by the patient of a non usual crisis.
    - Current treatment with nasal vasoconstrictors is ongoing
    - Head injury with suspicion of high intracranial pressure
    - Severe thoracic trauma or decompensated respiratory insufficiency
    - Contraindications of intranasal administration
    - Contraindication to nitrous oxide
    - Contraindication to morphine
    - Opiacé fort (morphine, oxycodone, hydromorphone, fentanyl transmuqueux) reçu dans les 6 heures précédentes ;
    - Femme enceinte ou allaitante ;
    - Saturation en oxygène inférieure à 93 % ;
    - Coopération du patient impossible: agitation, altération de l’état cognitif ;
    - Incapacité de faire une autoévaluation de la douleur ;
    - Allergie ou intolérance connue aux opiacés ou au protoxyde d’azote ;
    - Abus ou addiction aux opioïdes ;
    - Insuffisance hépatocellulaire sévère ;
    - Insuffisance rénale sévère ;
    - Asthme sévère ou BPCO ;
    - Pneumopathie nécessitant oxygénothérapie
    - Présence de signes de gravité :
    • Tout signe de gravité respiratoire ;
    • Tout signe neurologique ou altération de la conscience (Score de Glasgow <15) ;
    • Fièvre élevée > 39°C ;
    • Signe d’intolérance d’une anémie aiguë ;
    • Signes de défaillance hémodynamique ;
    • Défaillance viscérale connue (ex. insuffisance rénale, Hypertension artérielle pulmonaire) ;
    • Description par le patient du caractère inhabituel de la crise.
    -Traitement en cours par des vasoconstricteurs nasaux
    -Traumatisme crânien avec suspicion d’hypertension intracrânienne ;
    -Traumatisme thoracique sévère ou insuffisance respiratoire décompensée ;
    -Contre-indication à l’administration intranasale;
    -Contre-indication au MEOPA;
    -Contre-indication à la morphine.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects relieved (numeric rating scale ≤ 3/10) 30 minutes after starting treatment in each group.
    Proportion de patients soulagés (Échelle évaluation numérique ≤3/10) 30 minutes après le début du traitement dans chacun des groupes
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 minutes after starting treatment
    30 minutes après le début du traitement
    E.5.2Secondary end point(s)
    • Side events occurring during management up to 4 hours after treatment initiation
    • Proportion of patients relieved (NRS ≤ 3/10) 15, 60 and 120 minutes after starting treatment.
    • Morphine consumption (mg) 60 and 120 minutes after starting treatment.
    • Time (minutes) to obtain an effective analgesia
    • Time (minutes) to obtain a venous access
    - Proportion de patients présentant au moins un évènement indésirable au cours de la prise en charge jusqu’à 4 heures après le début du traitement
    - Proportion de patients soulagés (EN≤3/10) 15, 60 et 120 minutes après le début du traitement.
    - Consommation de morphine en mg 60 et 120 minutes après le début du traitement.
    - Délai moyen d’obtention d’une analgésie efficace en minutes.
    - Délai moyen de pose de la voie veineuse en minutes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 4 hours after treatment initiation.
    • 15, 60 and 120 minutes after starting treatment.
    • 60 and 120 minutes after starting treatment.
    • from starting treatment to obtain an effective analgesia (minutes)
    • from starting treatment to obtain a venous access (minutes)
    - 4 heures après le début du traitement.
    - 15, 60 et 120 minutes après le début du traitement.
    - 60 et 120 minutes après le début du traitement.
    - de l'initiation du traitement jusqu'à obtenir une analgésie efficace en minutes.
    - de l'initiation du traitement jusqu'à obtenir la pose de la voie veineuse (minutes)
    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 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) 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 No
    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 trial2
    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 concerned8
    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
    last visit of the last subject
    derniere visite du dernier patient
    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 months6
    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: 196
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 196
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    - Subjects incapable of giving consent for physical reasons.
    - Subjects who need urgent care.
    - Patient incapable de donner son consentement pour des raisons physique.
    - Patient en situation d'urgence.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state196
    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
    aucun
    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 Decision2019-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-18
    P. End of Trial
    P.End of Trial StatusCompleted
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