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    Summary
    EudraCT Number:2015-000202-20
    Sponsor's Protocol Code Number:RC-P0041
    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:2015-06-19
    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 number2015-000202-20
    A.3Full title of the trial
    Effect and tolerance of ketamine's subcutaneous bolus during painful
    care, refractory of bedsore, ulcer, vascular wound care in palliative care
    units.
    Effet et tolérance de bolus sous-cutanés de kétamine lors de soins
    douloureux réfractaires d'escarres, d'ulcères et de plaies vasculaires en
    services de soins palliatifs.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Observe the analgesia effect and tolerance of IV injected ketamine
    during painful bedsore, ulcer or vascular wound care (bandages,
    cleansing) for hospitalized patients in palliative care units.
    Observer l'effet anti-douleur et la tolérance de kétamine injectéee par
    voie sous cutanée lors de soins douloureux d'escarres, d'ulcères ou de
    plaies vasculaires (pansements et nettoyage), chez des patients
    hospitalisés en services de soins palliatifs.
    A.3.2Name or abbreviated title of the trial where available
    KETAREF
    KETAREF
    A.4.1Sponsor's protocol code numberRC-P0041
    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 SponsorGroupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)
    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 supportGroupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGroupement des Hôpitaux de l’Institut Catholique de Lille (GHICL)
    B.5.2Functional name of contact pointCRA
    B.5.3 Address:
    B.5.3.1Street AddressDépartement de la Recherche Médicale- Hôpital Saint-Philibert, 115 Rue du Grand But
    B.5.3.2Town/ cityLomme
    B.5.3.3Post code59462
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320225731
    B.5.5Fax number+33320225767
    B.5.6E-mailhamez.melanie@ghicl.net
    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 KETAMINE PANPHARMA 50 mg/5 ml, solution injectable (I.M.-I.V.)
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    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: 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 KETAMINE PANPHARMA 250 mg/5 ml, solution injectable (I.V.-I.M.)
    D.2.1.1.2Name of the Marketing Authorisation holderPANPHARMA
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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: 3
    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 KETAMINE RENAUDIN 10 mg/ml, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderRENAUDIN
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    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: 4
    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 KETAMINE RENAUDIN 50 mg/ml, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderRENAUDIN
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE
    D.3.9.1CAS number 6740-88-1
    D.3.9.4EV Substance CodeSUB08365MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(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.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
    Patients’ palliative care for bedsores, ulcers or vascular wounds, which are general characteristics of the patient population that will be included: usually elderly, undernourished and of multiple pathologies.
    Patients en prise en charge palliative actée, présentant des escarres, ou ulcères ou plaies vasculaires. Caractéristiques générales de la population de patients qui seront inclus : souvent âgés, dénutris, porteurs de polypathologies.
    E.1.1.1Medical condition in easily understood language
    Patients’ palliative care for bedsores, ulcers or vascular wounds, which are general characteristics of the patient population : elderly, undernourished and of multiple pathologies.
    Patients en prise en charge palliative, présentant des escarres, ou ulcères ou plaies vasculaires. Caractéristiques générales de la population de patients : âgés, dénutris, plusieurs maladies
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10047079
    E.1.2Term Vascular injuries
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10045285
    E.1.2Term Ulcer
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10036651
    E.1.2Term Pressure sore
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10059513
    E.1.2Term Palliative care
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10040943
    E.1.2Term Skin ulcer
    E.1.2System Organ Class 10040785 - Skin and subcutaneous tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the symptomatic effect on pain and the comfort of ketamine’s sub-cutaneous bolus administered to adults hospitalized in palliative units during painful care of vascular wounds, ulcers and bedsores, not eased by opioid or Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) or for whom these treatments aren’t adapted (Entonox, in cases of disturbed consciousness) or for whom side effects are unbearable (drowsiness, confusion, nausea, vomiting, respiratory depression…).
    Evaluer l’effet symptomatique sur les douleurs et le confort de bolus sous cutanés de kétamine administrés à des adultes hospitalisés en unité de soins palliatifs, lors de soins douloureux de plaies vasculaires, d’ulcères et d’escarres, non soulagés par un opioïde ou par le MEOPA (mélange équimolaire d'oxygène et de protoxyde d'azote), ou pour lesquels ces traitements ne sont pas adaptés (MEOPA en cas de troubles de conscience), ou dont les effets secondaires sont insupportables (somnolence, confusion, nausées, vomissements, dépression respiratoire…)
    E.2.2Secondary objectives of the trial
    •Evaluate the tolerance of the sub-cutaneous administration of ketamine’s bolus, with protocol dosages and with the surveillance of:
    -Arterial pressure, heart frequency, respiratory frequency, saturation in visual oxygen
    -The appearance of neurodysleptic symptoms: confusion, perturbation of visual/hearing sensations, humor perturbation, hallucinations, agitation…
    -Appearance of hypersialorrhea, bronchial cluttering
    -Presence of nausea or vomiting
    -Presence of cephalgia or dizziness
    •Define a ketamine dosage administered in sub-cutaneous bolus, before painful caring in order to obtain the antalgic efficacy thanks to EVA < 3 or Algoplus scale < 2, and in a satisfactory efficacy/tolerance report for patients’ comfort.
    •Evaluer la tolérance de l’administration sous-cutanée de bolus de kétamine dans ces situations et aux posologies du protocole avec surveillance de :
    - la vigilance
    - la tension artérielle, fréquence cardiaque, fréquence respiratoire, saturation en oxygène
    - la survenue de symptômes neurodysleptiques : confusion, perturbations des sensations visuelles, auditives, de l’humeur, hallucinations, agitation…
    - l’apparition d’une hypersiallorhée, d’un encombrement bronchique
    - la présence de nausées ou vomissements
    -la présence de céphalées ou de vertiges

    •Définir une posologie de kétamine administrée en bolus sous-cutanés avant des soins douloureux pour obtenir une efficacité antalgique définie par une EVA <3 ou une échelle Algoplus <2, et dans un rapport efficacité/tolérance satisfaisant pour le confort des patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients of age (≥18 years old), hospitalized in palliative care units
    -Conscious or presenting disturbed consciousness but for whom the Rudkin score is ≤ 4 (eyes closed, response to light tactical stimulation)
    -For whom a palliative care is acted
    -No matter the progression and prognostic status
    -After the information is given to the patient (with the notification form given) and the written consent form is retrieved and when the state of cognition and vigilance allows it. In case of cognitive and consciousness disturbance, after informing and retrieving the written consent form from the patient’s trusted person, or a relative by default, for patients under guardianship after being informed and giving a consent form written by the legal representative.
    -Evened out on an analgesia level, without care
    -Who has not received ketamine for 60 days before inclusion no matter the indications
    -For whom bedsore, ulcer or vascular injuries have appeared and continue to be painful despite the administration of opioid bolus with the painful evaluation regarding the visual analogic scale (EVA) ≥ 5/10, or regarding the evaluation of the Algoplus pain behavior scale ≥ 2, or for whom the opioid treatment cannot be administered due to the presence of adverse side effects (drowsiness, confusion, nausea, vomiting, respiratory depression…)
    -And for whom caring under Entonox (a medical analgesic gas which is a mix of nitrous oxide and oxygen) is inefficient or not compatible.
    -Lack of easy venous access
    - Patients majeurs (≥18 ans), hospitalisés en unité de soins palliatifs
    - Conscients ou présentant des troubles de conscience, mais dont le score de Rudkin est ≤ 4 (yeux fermés, réponse aux stimulations tactiles légères)
    - Pour lesquels une prise en charge palliative est actée
    - Quel que soit leur statut évolutif et pronostique
    - Après information donnée au patient (lettre d’information remise) et recueil de son consentement écrit, lorsque son état de vigilance et cognitif le permet. En cas de troubles de conscience ou cognitifs, après information et consentement écrit de sa personne de confiance ou, à défaut, d’un de ses proches, pour les patients sous tutelle après information et consentement écrit de son représentant légal.
    - Equilibrés sur le plan antalgique, en dehors des soins
    - N’ayant pas reçu de kétamine depuis 60 jours avant l’inclusion dans quelque indication que ce soit.
    - Chez qui des soins de lésions d’escarres, d’ulcères ou vasculaires sont réalisés et restent douloureux malgré la réalisation de bolus d’opioïdes, avec une évaluation douloureuse sur l’échelle visuelle analogique (EVA) ≥ 5/10, ou sur l’échelle d’évaluation comportementale de la douleur Algoplus ≥ 2, ou pour lesquels le traitement opioïde ne peut être administré en raison de survenue d’effets secondaires mal tolérés (somnolence, confusion, nausées, vomissements, dépression respiratoire…)
    -Et pour qui la réalisation des soins sous MEOPA (mélange équimolaire oxygène- protoxyde d’azote) est inefficace ou inadaptée.
    -Absence de voie veineuse facilement utilisable
    E.4Principal exclusion criteria
    -Contraindication of Ketamine in case of anesthesia (AMM) : allergy, porphyria
    -Late stage heart failure
    -Intracranious hypertension
    -Acute heart attack phase
    -Unstable psychosis
    -Presence of agitation
    -Pregnant woman
    -Patient with no affiliation to a social security system
    -Contraindication of Midazolam: known hypersensitivity to benzodiazepines or any other know excipient of the product, acute respiratory depression
    Contre-indications de la kétamine dans le cadre de l’anesthésie (AMM) : allergie, porphyrie.
    - Insuffisance cardiaque terminale,
    - HTIC (hypertension intra crânienne),
    - phase Phase aigüe d’un infarctus du myocarde,
    - psychoses Psychoses non stabilisées,
    - présence Présence d’une agitation.
    - Femmes enceintes.
    - Patient non affilié à un régime de sécurité sociale
    - Contre-indications au midazolam : hypersensibilité connue aux benzodiazépines ou à tout excipient connu du produit, dépression respiratoire aigüe.
    E.5 End points
    E.5.1Primary end point(s)
    •Evaluation of pain in different moments or care via the two approved scales :
    -The visual analogic scale (EVA) for communicative and coherent patients
    -The behavior Algoplus scale for non-communicative patients or patients with cognitive or consciousness disturbances
    •The evaluation of the patient’s comfort, by the person caring for the patient via a visual analogic scale at different times of care.
    Evaluation de la douleur à différents temps du soin à partir de 2 échelles validées :
    -l’échelle visuelle analogique (EVA) pour les patients communicants et cohérents.
    - l’échelle comportementale Algoplus chez les patients non communicants ou présentant des troubles cognitifs ou de conscience.

    Evaluation du confort du patient par le soignant sur une échelle visuelle analogique à différents temps du soin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 3 hours
    après 3 heures
    E.5.2Secondary end point(s)
    •Evaluation of the tolerance of treatment via the observation of adverse effects that can arise in:
    -Vigilance stat (Rudkin score)
    -Heart frequency and arterial tension
    -Respiratory frequency and saturation in O2
    -Presence of confusion
    -Presence of psychodysleptic symptoms : disturbance of visual/hearing sensations, humor disturbance, hallucinations, agitation
    -Presence of hypersialorrhea
    -Presence of bronchial clotting
    -Presence of nausea or vomiting
    -Observation of the appearance of other adverse events
    •Establishing ketamine sub-cutaneous dosage needed for obtaining an analgesic efficiency defined by EVA < 3 or a Algoplus < 2.
    Evaluation de la tolérance du traitement par l'observation des effets
    secondaires indésirables pouvant survenir sur :
    - l'état de vigilance (score de Rudkin)
    - la fréquence cardiaque et tension artérielle
    - la fréquence respiratoire et saturation en O2
    - la présence d'une confusion
    - la présence de symptômes psychodysleptiques : perturbations des
    sensations visuelles, auditives, de l'humeur, hallucinations, agitation
    - la présence d'une hypersiallorhée
    XML File Identifier: +tvZgLprL5GrVpxSTmKFxDo0LMM=
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    - la présence d'un encombrement bronchique
    - la présence de nausées ou de vomissements
    - l'observation de la survenue d'un autre effet indésirable
    Détermination de la posologie de kétamine sous-cutanée nécessaire à
    l'obtention d'une efficacité antalgique définie par une EVA<3 ou une
    Algoplus<2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 3 hours
    après 3 heures
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    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 concerned9
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    presenting disturbed consciousness ( Rudkin score is ≤ 4 ) or disturbed cognitive, patients under guardianship
    personnes présentant des troubles de conscience (Rudkin ≤ 4 ) ou cognitifs, personnes sous tutelles
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    If the protocol administered for this study was effective, well tolerated and allowed a decrease of the pains during the realization of the care for the patient, it can be again administered during the later care, if the patient wishes it, except the study, and according to the recommendations of the ANSM.
    Si le protocole administré pour cette étude a été efficace, bien toléré et a permis une diminution des douleurs lors de la réalisation des soins pour le patient, il pourra être à nouveau administré lors des soins ultérieurs, si le patient le souhaite, en dehors de l’étude, et selon les recommandations de l’ANSM.
    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 Decision2015-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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