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    Clinical Trial Results:
    The NordCAN study: Cannabis treatment in hand osteoarthritis and psoriatic arthritis. A randomized, double-blind placebo controlled study

    Summary
    EudraCT number
    		 2017-003574-13
    Trial protocol
    		 DK  
    Global end of trial date
    01 Jun 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Oct 2022
    First version publication date
    22 Oct 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    020683
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dept. of rheumatology Aalborg
    Sponsor organisation address
    Reberbansgade 15, Aalborg, Denmark,
    Public contact
    Jonathan Vela MD., Dept. of rheumatology Aalborg, +45 97664018, j.vela@rn.dk
    Scientific contact
    Jonathan Vela MD., Dept. of rheumatology Aalborg, +45 97664018, j.vela@rn.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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
    Protection of trial subjects
    The trial was approved by the Danish Human Ethics Committee (N-20170074), the Danish Medicines Agency (2017091784), and the Danish Data Protection Agency (2017-245). The NordCAN project was registered on ClinicalTrials.gov (NTC03693833) and in the European Clinical Trials database (2017-003574-13). The trial was continually monitored by the Good Clinical Practice (GCP) unit of Aalborg University Hospital, externally audited by the Danish Medicine Agency, and was conducted in accordance with the Declaration of Helsinki, GCP, and Danish regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 136
    Worldwide total number of subjects
    136
    EEA total number of subjects
    136
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    84
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients with PsA or Hand-OA were included between November 2018 and September 2020. at the Rheu- matological Research Unit at the Department of Rheumatology, Aalborg University Hospital, Denmark

    Pre-assignment
    Screening details
    		 152 patients screened. 13 excluded (3 due to inadequate pain intensity, 7 declined to participate, 3 did not fill diagnostic criteria).

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Medicine and placebo was identical and randomisation was performed off site. Randomisation was broken after analysis and only then did participants and staff learn what medications the patients received.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cannabidiol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cannabidiol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Patients initially received either oral CBD 10 mg or a placebo tablet once daily with the dose increased to 10 mg twice daily after 2 weeks. Patients were contacted by the investigator after 4 weeks, and those not experiencing a pain reduction of more than 20 mm on the VAS had their dose increased to 10 mg thrice daily until the end of treatment period.

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Se CBD regimen

    Number of subjects in period 1
    		Cannabidiol Placebo
    Started
    70
    66
    Completed
    68
    61
    Not completed
    2
    5
         Consent withdrawn by subject
    -
    2
         Misdiagnosed
    -
    1
         Lost to follow-up
    2
    -
         Protocol deviation
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Cannabidiol Placebo Total
    Number of subjects
    		 70 66 136
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 62.00 (56.25 to 68.00) 61.50 (53.00 to 70.75) -
    Gender categorical
    Units: Subjects
        Female
    		 42 46 88
        Male
    		 28 20 48

    End points

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    End points reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: VAS pain

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    End point title
    		 VAS pain
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Cannabidiol Placebo
    Number of subjects analysed
    70
    66
    Units: millimetre
        number (confidence interval 95%)
    11.68 (5.33 to 18.0)
    11.45 (5.01 to 18.5)
    Statistical analysis title
    		 Mean difference in pain at study end
    Comparison groups
    Cannabidiol v Placebo
    Number of subjects included in analysis
    136
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.96
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.41
         upper limit
    		 9.9
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 None
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Cannabidiol Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 70 (2.86%)
    2 / 66 (3.03%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ductal carcinoma
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malignant hypertension
    Additional description: Patient had a measure of high blood pressure and was sent to the D. Normalised in the ED without requiring further intervention.
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lipothymia
    Additional description: Patient had a fainting spell and was brought to the AE. No cause for the fainting spell was found
         subjects affected / exposed
    1 / 70 (1.43%)
    0 / 66 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Shoulder fracture
    Additional description: Shoulder fracture due to fall
         subjects affected / exposed
    0 / 70 (0.00%)
    1 / 66 (1.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Cannabidiol Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 70 (42.86%)
    26 / 66 (39.39%)
    Cardiac disorders
    Cardiovascular
         subjects affected / exposed
    3 / 70 (4.29%)
    4 / 66 (6.06%)
         occurrences all number
    4
    4
    Gastrointestinal disorders
    Lower GI
         subjects affected / exposed
    2 / 70 (2.86%)
    6 / 66 (9.09%)
         occurrences all number
    2
    9
    Upper GI
         subjects affected / exposed
    5 / 70 (7.14%)
    9 / 66 (13.64%)
         occurrences all number
    6
    10
    Respiratory, thoracic and mediastinal disorders
    Ear nose and throat
         subjects affected / exposed
    5 / 70 (7.14%)
    0 / 66 (0.00%)
         occurrences all number
    8
    0
    Airways
         subjects affected / exposed
    6 / 70 (8.57%)
    5 / 66 (7.58%)
         occurrences all number
    7
    6
    Skin and subcutaneous tissue disorders
    Dermal
         subjects affected / exposed
    2 / 70 (2.86%)
    0 / 66 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Mood
         subjects affected / exposed
    3 / 70 (4.29%)
    3 / 66 (4.55%)
         occurrences all number
    4
    3
    Renal and urinary disorders
    Urogenital
         subjects affected / exposed
    0 / 70 (0.00%)
    4 / 66 (6.06%)
         occurrences all number
    0
    5
    Musculoskeletal and connective tissue disorders
    Musculoskeletal
         subjects affected / exposed
    6 / 70 (8.57%)
    7 / 66 (10.61%)
         occurrences all number
    11
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    14 Nov 2019
    Firm that helps with secondary analysis of the trial medicin failed a GMP inspection.
    02 Mar 2020
    10 Mar 2020
    COVID-19
    17 Jun 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/34510141
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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