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    Summary
    EudraCT Number:2017-003574-13
    Sponsor's Protocol Code Number:020683
    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:2018-03-08
    Trial results View 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 number2017-003574-13
    A.3Full title of the trial
    The NordCAN study: Cannabis treatment in hand osteoarthritis and psoriatic arthritis. A randomized, double-blind placebo controlled study
    NordCAN studiet: Cannabis behandling ved hånd artrose og psoriasisgigt. Et randomiseret, dobbelt-blindet placebo kontrolleret studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medical cannabis for the treatment of pain in patients with hand osteoarthritis and psoriatic arthritis.
    Medicinsk cannabis til behandling af smerter ved slidgigt i hænderne eller psoriasis gigt.
    A.3.2Name or abbreviated title of the trial where available
    NordCAN
    NordCAN
    A.4.1Sponsor's protocol code number020683
    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 SponsorAalborg university hospital dept. of rheumatology
    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 supportRegion Nordjyllands Sundhedsvidenskabelige Forskningsfond
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportForskningenshus uddannelse og innovation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAalborg University Hospital dept. of reumatology
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportAalborg University
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of rheumatology Aalborg
    B.5.2Functional name of contact pointJonathan Vela MD.
    B.5.3 Address:
    B.5.3.1Street AddressReberbansgade 15 Forhallen
    B.5.3.2Town/ cityAalborg
    B.5.3.3Post code9000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4597664018
    B.5.6E-mailj.vela@rn.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 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 nameCannabidiol
    D.3.2Product code CBD
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCBD
    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 milligram(s)
    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 Yes
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic Arthritis
    Hand Osteoarthritis
    Psoriasis gigt
    Hånd artrose
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    Hand osteoarthritis
    Psoriasis gigt
    Slidgigt i hænderne
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019115
    E.1.2Term Hand osteoarthritis
    E.1.2System Organ Class 100000004859
    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 effect of cannabidiol (CBD) on pain in patients with nodal non-erosive hand osteoarthritis (Hand-OA) and psoriatic arthritis (PsA) after 12 weeks
    At undersøge effekten af cannabidiol tabletter på smerte hos patienter med håndartrose eller psoriasis gigt efter 12 uger
    E.2.2Secondary objectives of the trial
    o Changes is VAS pain during the last 24 hours from baseline to 24 weeks.
    o Changes in VAS global from baseline to 12 weeks and 24 weeks.
    o Changes in function scores from baseline to 12 weeks.
    o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks.
    o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks (Hand-OA only).
    o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks.
    o Ændring i VAS smerte gennem sidste 24 timer fra baseline til 24 uger
    o Ændring i VAS global gennem sidste 24 timer fra baseline til 12 og 24 uger.
    o Ændring i funktions score fra baseline til 12 weeks.
    o Ændring i centrale smerte mekanismer målt med quantitativ sensorisk testing fra baseline til 12 og 24 uger
    o Ændring i greb og knibe styrke fra baseline til 12 uger og 24 uger hos hånd-oa patienter
    o Inflammatorisk og degenerative biomarkører måles og sammenlignes mellem baseline og 12 uger
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pain profile study (non-pharmacological)
    To assess peripheral and central pain mechanisms in patients with nodal non-erosive hand osteoarthritis (Hand-OA), psoriatic arthritis (PsA) compared with healthy controls.

    Date: 01.01.18 version 1.0
    Primary efficacy analysis:
    o Difference in conditioned pain modulation between groups


    Smerte profileringsstudie
    At undersøge perifær og centrale smertemekanismer i patienter med nodal non-erosiv håndartrose og psoriasis artrit sammenlignet med raske kontroller.

    Dato: 01.01.18 version 1.0
    Primær endpoint:
    o Forskel i conditioned pain modulation mellem grupperne
    E.3Principal inclusion criteria
    Hand-OA:
    Patients (18 years or older) with Hand-OA according to the American collage of rheumatology (ACR) criteria (1990)

    Hand-OA of the phenotype: Nodal, Non-erosive.

    Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

    100mm VAS pain during the last 24 hours over or equal to 30mm

    PsA:

    Patients (18 years or older) with PsA according to the classification criteria for psoriatic arthritis CASPAR criteria (2006)

    Ability and willingness to give written informed consent and to meet the requirements of the study protocol.

    100mm VAS pain during the last 24 hours over or equal to 30mm
    Inklusions kriterier Hånd-OA:

    Mænd og kvinder i alder over 18 år, Opfylder American College of Reumatology (ACR) kriterierne for Hånd-OA.

    Hånd-OA type: Nodal, Non-Erosiv Hånd-OA

    Evne og ønske om at afgive informeret samtykke og følge retningslinjerne i studieprotokollen.

    VAS smerte gennem sidste 24timer over eller = 30mm

    Inklusions kriterier PsA:

    Mænd og kvinder i alder over 18 år, Opfylder Classification Criteria for Psoriatic Arthritis (CASPAR) kriterierne for PsA

    Evne og ønske om at afgive informeret samtykke og følge retningslinjerne i studieprotokollen.

    VAS smerte gennem sidste 24timer over eller = 30mm
    E.4Principal exclusion criteria
    Hand-Oa and PsA
    1. Other known inflammatory rheumatic disease (i.e. Rheumatoid arthritis, gout)
    2. Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
    3. Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs
    4. History of psychiatric disease that contraindicates use of medical cannabis treatment (i.e. schizophrenia).
    • Kendt med anden betændelses betinget reumatologisk lidelse (f.eks.ledgigt, urinsur gigt)

    • Konkurrende smertelidelse (f.eks Fibromyalgi, Karpal tunnelsyndrom, Polyneuropati)

    • Addiktiv eller tidligere addiktiv adfærd defineret som misbrug af hash, opioder eller andre euforiserende stoffer

    • Tidligere eller aktuelle neurologiske eller psykiske sygdomme som kontraindicerer brug af medicinsk cannabis.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in VAS pain during the last 24 hours from baseline to 12 weeks
    Forskel i VAS gennem de sidste 24 timer mellem baseline og 12 uger
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 uger
    E.5.2Secondary end point(s)
    o Changes is VAS pain during the last 24 hours from baseline to 24 weeks.
    o Changes in VAS global from baseline to 12 weeks and 24 weeks.
    o Changes in function scores from baseline to 12 and 24 weeks.
    o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks.
    o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks*.
    o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks and 24 weeks will be made.
    o Ændring i VAS smerte gennem sidste 24 timer fra baseline til 24 uger..
    o Ændring i VAS global gennem sidste 24 timer fra baseline til 12 og 24 uger.
    o Ændring i funktions score fra baseline til 12 og 24 uger.
    o Ændring i centrale smerte mekanismer målt med quantitativ sensorisk testing fra baseline til 12 og 24 uger
    o Ændring i greb og knibe styrke fra baseline til 12 uger og 24 uger hos hånd-oa patienter
    o Inflammatorisk og degenerative biomarkører måles og sammenlignes mellem baseline og 12 uger samt 24 uger.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12-24weeks
    12-24uger
    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 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 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) 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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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
    Ingen
    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 Decision2018-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-01
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