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    Summary
    EudraCT Number:2018-000080-85
    Sponsor's Protocol Code Number:17-245
    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:2018-09-07
    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 number2018-000080-85
    A.3Full title of the trial
    Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients receiving palliative care
    Etude pilote du profil pharmacocinétique du paracétamol par voie sous cutanée versus voie intraveineuse chez les patients en soins palliatifs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients receiving palliative care
    Etude pilote du profil pharmacocinétique du paracétamol par voie sous cutanée versus voie intraveineuse chez les patients en soins palliatifs
    A.3.2Name or abbreviated title of the trial where available
    ParaSCIVPallia
    ParaSCIVPallia
    A.4.1Sponsor's protocol code number17-245
    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 CAEN
    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 supportAPRI 2017 (CHU CAEN)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU CAEN
    B.5.2Functional name of contact pointInvestigator
    B.5.3 Address:
    B.5.3.1Street AddressCHU CAEN
    B.5.3.2Town/ city14033
    B.5.3.4CountryFrance
    B.5.4Telephone number33231065149
    B.5.5Fax number33231065068
    B.5.6E-mailcsech-m@chu-caen.fr
    D. IMP Identification
    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
    Major patients in palliative care
    Patients majeurs en prise en charge palliative
    E.1.1.1Medical condition in easily understood language
    Major patients in palliative care
    Patients majeurs en prise en charge palliative
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the pharmacokinetic profile of Paracetamol subcutaneously in palliative care patients and compare it to the intravenous pharmacokinetic profile in the same patients
    Déterminer le profil pharmacocinétique du Paracétamol en sous-cutanée chez les patients en soins palliatifs et le comparer au profil pharmacocinétique en intraveineux chez les mêmes patients
    E.2.2Secondary objectives of the trial
    • -Effectiveness on pain control
    • Tolerance of the route of administration: skin monitoring (change in color, appearance of edema, cutaneous necrosis, allergic reaction) and monitoring of the onset of pain at the puncture by a EN
    • - Overall tolerance
    • -Efficacité sur le contrôle de la douleur
    • -Tolérance de la voie d’administration : surveillance cutanée (modification de la couleur, apparition d’œdèmes, d’une nécrose cutanée, d’une réaction allergique) et surveillance de l’apparition d’une douleur au niveau du point de ponction par une EN
    • - Tolérance globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient hospitalized (18 years or older) with a pathology in palliative care (defined by WHO as active, complete care, given to patients whose condition does not respond to curative treatment)
    • -Disposant of functional central IV pathway with presence of reflux (implantable venous site, picc-line, central line)
    • -Presenting spontaneous pain, not related to the care, with a numerical scale (EN) superior to 3/10 or having a prescription of paracetamol in systematic in its usual treatment.
    • Patient able to self-assess pain with an EN
    • Absence of contraindication to paracetamol
    • -Absence of contraindication to the administration of alternative analgesics (weak opioid, strong opioid, NSAID) during the time of the realization of the protocol and periods of wash out.
    • Possibility of absence of paracetamol in the previous 24 hours (absence of fever for example)
    • Have a blood test that is less than 7 days old and does not show hepatic or end-stage renal insufficiency that contraindicates paracetamol administration.
    • Patient Agreement to Participate in the Study, Collection of Signed Informed Consent
    • The need to be affiliated to the social security system
    • -Patient hospitalisé (18 ans ou plus) présentant une pathologie en prise charge palliative (définit par l’OMS comme des soins actifs, complets, donnés aux malades dont l’affection ne répond pas au traitement curatif)
    • -Disposant d’une voie IV centrale fonctionnelle avec présence d’un reflux (site veineux implantable, picc-line, voie centrale)
    • -Présentant une douleur spontanée, non liée aux soins, avec une échelle numérique (EN) supérieur à 3/10 ou ayant une prescription de paracétamol en systématique dans son traitement habituel.
    • -Patient en capacité d’autoévaluer sa douleur avec une EN
    • -Absence de contre-indication au paracétamol
    • -Absence de contre-indication à l’administration d’antalgiques alternatifs (opioïde faibles, opioïde forts, AINS) pendant le temps de la réalisation du protocole et des périodes de wash out.
    • -Possibilité d’absence de prise de paracétamol dans les 24h précédentes (absence de fièvre par exemple)
    • -Disposer d’un bilan sanguin datant de moins de 7 jours, ne montrant pas d’insuffisance hépatique ou rénale terminale contre-indiquant l’administration du paracétamol.
    • -Accord du patient de participer à l’étude, recueil de la signature du consentement éclairé
    • -La nécessité d’être affilié au régime de la sécurité sociale
    E.4Principal exclusion criteria
    -Patient under 18 years
    -Patient under legal protection
    -Patient participating in another research protocol or having participated in another protocol within less than 30 days
    -Patient with contraindications to paracetamol
    -Weight less than 50kg
    -Patient not in a palliative situation (as defined by the WHO) of his illness
    -Patient with a contraindication to the administration of a subcutaneous treatment (infection or edema at the point of puncture)
    -Pregnant or lactating woman
    -Patient who received a paracetamol administration in the previous 24 hours
    -Patient who received a low opioid (immediate-release tramadol) within 2 hours or a strong opioid (morphine or oxycodone immediate-release injection or oral, fentanyl injection or transmucosal) in the hour before the administration of paracetamol. (As part of the monitoring of tolerance)
    -Patient with a fever
    -Absence of functional venous pathway
    -Absence of communication possible
    -Patient de moins de 18 ans
    -Patient sous protection juridique
    -Patient participant à un autre protocole de recherche ou ayant participé à un autre protocole dans un délai inférieur à 30 jours
    -Patient présentant des contre-indications au paracétamol
    -Poids inférieur à 50kg
    -Patient n’étant pas en situation palliative (comme définit par l’OMS) de sa maladie
    -Patient présentant une contre-indication à l’administration d’un traitement en sous cutanée (infection ou œdème au niveau du point de ponction)
    -Femme enceinte ou allaitante
    -Patient ayant bénéficié d’une administration de paracétamol dans les 24 heures précédentes
    -Patient ayant reçu un opioïde Faible (tramadol à libération immédiate) dans les 2 heures ou un opioïde Fort (morphine ou oxycodone à libération immédiate injectable ou orale, fentanyl injectable ou transmuqueux) dans l’heure précédent l’administration du paracétamol. (Dans le cadre de la surveillance de la tolérance)
    -Patient présentant une fièvre
    -Absence de voie veineuse fonctionnelle
    -Absence de communication possible
    E.5 End points
    E.5.1Primary end point(s)
    Measurement of paracetamolemia to determine AUC0-t, AUC0-00, Cmax, Vd and t1 / 2 for each mode of administration for the same patient and achievement of pharmacokinetic curve.
    Mesure de la paracétamolémie afin de déterminer AUC0-t, AUC0-00, Cmax , Vd et t1/2 pour chaque mode d’administration pour un même patient et réalisation de courbe de pharmacocinétique.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 hours
    8 heures
    E.5.2Secondary end point(s)
    -Efficacy on pain control
    -Treatment route intolerance: skin monitoring (change in color, appearance of edema, skin necrosis, allergic reaction) and monitoring of the appearance of pain at the point of puncture by an EN
    - Global tolerance
    -Efficacité sur le contrôle de la douleur
    -Tolérance de la voie d’administration : surveillance cutanée (modification de la couleur, apparition d’œdèmes, d’une nécrose cutanée, d’une réaction allergique) et surveillance de l’apparition d’une douleur au niveau du point de ponction par une EN
    - Tolérance globale
    E.5.2.1Timepoint(s) of evaluation of this end point
    day 30
    J 30
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.2.3.1Comparator description
    voie d'administration: SC ou IV
    route of administration: SC or IV
    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 No
    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
    30 days
    30 jours
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state20
    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
    non
    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 Decision2018-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-30
    P. End of Trial
    P.End of Trial StatusOngoing
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