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    Summary
    EudraCT Number:2022-002424-12
    Sponsor's Protocol Code Number:KETA-TEAM
    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:2022-07-28
    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 number2022-002424-12
    A.3Full title of the trial
    KETA-TEAM A Phase 2 Study to Assess the Safety and Efficacy of Ketamine, Treatment for Endometriosis-related chronic pain as Analgesic in Médipôle
    KETA-TEAM Etude de phase 2 : évaluation de l’efficacité et de la tolérance de la KETAmine - Traitement de la douleur chronique liée à l’Endométriose- comme Analgésique au Médipôle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    KETA-TEAM study of Ketamine in Endometriosis
    KETA-TEAM étude de la kétamine dans l'endométriose
    A.3.2Name or abbreviated title of the trial where available
    KETA-TEAM
    A.4.1Sponsor's protocol code numberKETA-TEAM
    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 SponsorMédipôle Hôpital Mutualiste
    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 supportMédipôle Hôpital Mutualiste
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMédipôle Hôpital Mutualiste
    B.5.2Functional name of contact pointLaetitia Paradisi
    B.5.3 Address:
    B.5.3.1Street Address158 rue Léon Blum
    B.5.3.2Town/ cityVilleurbanne
    B.5.3.3Post code69100
    B.5.3.4CountryFrance
    B.5.4Telephone number330481655296
    B.5.6E-maill.paradisi-prieur@resamut.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 KETAMINE RENAUDIN 10 mg/mL, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE RENAUDIN
    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.3.1Product nameKETAMINE RENAUDIN 10 mg/mL, solution injectable
    D.3.2Product code 34009 578 524 7 4
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    Endometriosis with refractory chronic pelvic pain
    Endométriose avec douleur pelvienne chronique réfractaire
    E.1.1.1Medical condition in easily understood language
    endometriosis
    endométriose
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014778
    E.1.2Term Endometriosis
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Ketamine treatment on endometriosis-related chronic pain
    Évaluer l'efficacité de la kétamine sur les douleurs chroniques liées à l'endométriose
    E.2.2Secondary objectives of the trial
    To assess the step 2 and 3 analgesics
    consumption during Ketamine use and over 1 month after its last administration / To assess the efficacy of Ketamine
    treatment on quality of life in patients with endometriosis up to 1 month after its end / To assess the safety of Ketamine treatment on endometriosis-related chronic pain
    Évaluer la consommation d'analgésiques de niveau 2 et 3 pendant l'utilisation de la Kétamine et un mois après la dernière administration / Évaluer l'efficacité de la Kétamine sur la qualité de vie des patientes atteintes d'endométriose jusqu'à un mois après la dernière administration / Évaluer la tolérance de la kétamine sur les douleurs chroniques liées à l'endométriose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adults women who suffer from endometriosis with refractory chronic pelvic pain with clinically normal renal and hepatic functions, signing informed consent
    femmes adultes souffrant d'endométriose avec des douleurs chroniques pelviennes réfractaires
    Pour pouvoir participer à cette étude avec des fonctions rénales et hépatiques cliniquement normales, et qui acceptent de participer en signant un consentement éclairé
    E.4Principal exclusion criteria
    high blood pressure, cardiac insufficiency, history of stroke or cerebral trauma.
    Pregnant and breastfeeding women.
    History of drug abuse or dependence.
    hypertension artérielle, insuffisance cardiaque, antécédent d'AVC ou de traumatisme cérébral.
    Femmes enceintes ou allaitantes. Antécédent d'abus de drogue ou de dépendance.
    E.5 End points
    E.5.1Primary end point(s)
    Pain level evaluated by the Pelvic Pain Sensitization Score (PPSS) 1 month after the 3-dose treatment
    Score de douleur évalué par le Pelvic Pain Sensitization Score (PPSS) 1 mois après les 3 doses de traitement
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after the 3-dose treatment
    1 mois après les 3 doses de traitement
    E.5.2Secondary end point(s)
    Step 2 and 3 analgesics consumption during Ketamine use and over 1 month after its last administration / Quality of life evaluated by the EHP-5,
    HAD scale and return to daily activities
    every month during 3 months / Incidence and severity of AEs and SAEs
    Consommation d'analgésiques de niveau 2 et 3 pendant l'utilisation de la Kétamine et un mois après la dernière administration / Qualité de vie évaluée par l'EHP-5, l'échelle HAD et le retour aux activités quotidiennes chaque mois pendant 3 mois / Incidence et sévérité des EI et EIG
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 month after the 3-dose treatment
    1 mois après les 3 doses de traitement
    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) 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 Yes
    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 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
    Last visit of the last subject
    dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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)
    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 Decision2022-11-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
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