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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-002318-15
    Sponsor's Protocol Code Number:010921
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-07-12
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2021-002318-15
    A.3Full title of the trial
    A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs
    Farmakologisk forsøg med Sativex® og gentamicin til optimeret farmakologisk behandling af ældre med fokus på appetitstimulering og renale risikolægemidler
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pharmacological trial with Sativex® and gentamicin for optimized pharmacological treatment of older patients with a focus on appetite stimulation and renal risk drugs
    A.3.2Name or abbreviated title of the trial where available
    CanPAN
    A.4.1Sponsor's protocol code number010921
    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 SponsorCopenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research
    B.1.3.4CountryDenmark
    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 supportUdviklings- og Forskningspuljen
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportFonden til Lægevidenskabens Fremme
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportStrategiske forskningsmidler Amager og Hvidovre Hospital
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportRegion Hovedstadens Postdoc pulje
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportSygehusapotekers Forsknings og Udviklings Pulje
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCopenhagen University Hospital, Amager and Hvidovre, Department of Clinical Research
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressKettegaard Allé 30
    B.5.3.2Town/ cityHvidove
    B.5.3.3Post code2650
    B.5.3.4CountryDenmark
    B.5.6E-mailrikke.lundsgaard.nielsen@regionh.dk
    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.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDronabinol
    D.3.9.3Other descriptive nameDELTA-9-TETRAHYDROCANNABINOL
    D.3.9.4EV Substance CodeSUB27785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.3Other descriptive nameCANNABIDIOL
    D.3.9.4EV Substance CodeSUB26600
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 Hexamycin
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 Concentrate for solution for injection/infusion
    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 INNGENTAMICIN SULFATE
    D.3.9.1CAS number 1405-41-0
    D.3.9.4EV Substance CodeSUB02327MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboOromucosal spray
    D.8.4Route of administration of the placeboOromucosal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    Malnutrition, poor appetite, kidney function in older medical patients
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061273
    E.1.2Term Malnutrition
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002646
    E.1.2Term Anorexia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10061428
    E.1.2Term Decreased appetite
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10056720
    E.1.2Term Muscle mass
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10053349
    E.1.2Term Pharmacokinetic study
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10018355
    E.1.2Term Glomerular filtration rate
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The CanPAN trial consists of two studies each with a primary objective

    - Study 1:
    To investigate if Sativex® has appetite stimulating properties defined as increased energy intake compared to placebo

    -Study 2:
    To compare the performance of kidney function estimates based on endogenous biomarker(s), creatinine clearance (24 hours urine collection) and measured GFR (mGFR) for predicting gentamicin clearance.
    E.2.2Secondary objectives of the trial
    The CanPAN trial consists of two studies each with secondary objectives

    - Study 1:
    To develop a pharmacokinetic-pharmacodynamic model, gain knowledge about the effects of Sativex® on other markers of appetite and safety parameters and on the intraocular pressure

    - Study 2:
    If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between GFR estimates, creatinine clearance and mGFR.
    Correlation coefficient between clearance gentamicin and clearance eGFR/creatinine clearance/mGFR.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ≥70 years
    Admitted to the Department of Emergency Medicine, Hvidovre Hospital
    Can cooperate cognitively
    Risk of malnutrition defined by NRS-2002 score ≥3
    Low appetite / age-related anorexia measured with SNAQ score ≤14
    BMI ≤25
    Must be able to read and understand Danish
    Postmenopausal defined as missed periods for at least 12 months before the start of the trial
    E.4Principal exclusion criteria
    Regular use of medical cannabis (patient reported)
    Use of medical cannabis within 14 days at baseline (patient reported)
    Recognized or suspected psychotic illness in the subject or his family (medical record and patient report)
    Severe personality disorders (journal)
    Significant psychiatric disorder in addition to mild to moderate depression (journal)
    Allergy to the ingredients of Sativex®, placebo and Hexamycin® (patient reported)
    Terminal diagnosis (journal)
    Cancer disease (journal)
    Liver transplant (journal)
    Chronic eGFR ≤15 mL / min2 or dialysis treatment (journal)
    Pacemaker (journal)
    Epilepsy (journal)
    Recurrent seizures (journal)
    Severe cardiovascular disease NYHA IV (journal)
    Previous heart attack (journal)
    Uncontrolled hypertension (journal)
    Cardiac arrhythmias (journal)
    Food intolerance to the ingredients in the test meals (patient reported)
    Vegetarian and vegan (patient reported)
    Unwilling to avoid driving for up to 72 hours after administration of Sativex® (patient-reported)
    Unwilling to avoid alcohol 24 hours up to the trial days (patient reported)
    Patients with ascites (medical record)
    Patients with significant edema on the days of the trial (medical record / visual inspection)
    E.5 End points
    E.5.1Primary end point(s)
    The CanPAN trial consists of two studies each with a primary endpoint

    - Study 1: Difference in energy intake (kJ) measured at a test meal between Sativex® and placebo

    - Study 2: If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between the use of eGFR panel and mGFR.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Study 1: Difference in energy intake (kJ)between Sativex® and placebo on testday 1 and testday 2.

    Study 2: The day of Gentamicin administration.
    E.5.2Secondary end point(s)
    The CanPAN trial consists of two studies each with secondary outcomes
    - Study 1:
    Population-based pharmacokinetic-pharmacodynamic modeling of Sativex® and its metabolites
    Difference in appetite as a combined appetite score measured on VAS between Sativex® and placebo
    Difference in the appetite hormones total ghrelin and GLP-1 between Sativex® and placebo
    Differences in eating patterns measured by Satorius' weight and mathematical modeling between Sativex® and placebo
    Safety parameters (CNS effects, cognition, balance disorders, blood pressure and heart rate) for Sativex®
    Difference in the intraocular pressure between Sativex® and placebo

    - Study 2
    If the predictive accuracy of the pharmacokinetic modeling of gentamicin differs between eGFRkreatinin, eGFRcomb, eGFRpanel, creatinine clearance and mGFR as covariate.
    Correlation coefficient between clearance gentamicin and clearance eGFR/creatinine clearance/mGFR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Study 1:
    - Measured between Sativex® and placebo on testday 1 and testday 2 -
    Difference in appetite as a combined appetite score measured on VAS between Sativex® and placebo
    Difference in the appetite hormones total ghrelin and GLP-1 between Sativex® and placebo
    Differences in eating patterns measured by Satorius' weight and mathematical modeling between Sativex® and placebo
    Safety parameters (CNS effects, cognition, balance disorders, blood pressure and heart rate) for Sativex®
    Difference in the intraocular pressure between Sativex® and placebo
    - Measured after administration of Sativex -
    Population-based pharmacokinetic-pharmacodynamic modeling of Sativex® and its metabolites

    Study 2
    - The day of Gentamicin administration.
    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 Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic, pharmacodynamic trial and therapeutic exploratory
    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 No
    E.8.1.4Double blind Yes
    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 Yes
    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 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
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 69
    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 state69
    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
    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 Decision2021-08-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2025-01-29
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