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    Clinical Trial Results:
    Efficacy of Cannabidiol in Treatment of Pain due to symptomatic Osteoarthritis of the Knee: A randomized, double-blind, placebo-controlled

    Summary
    EudraCT number
    		 2019-003591-40
    Trial protocol
    		 AT  
    Global end of trial date
    29 Mar 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2024
    First version publication date
    23 Oct 2024
    Other versions
    Summary report(s)
    		 Cannabidiol Osteoarthristis Knee

    Trial information

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    Trial identification
    Sponsor protocol code
    131082019
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04607603
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna
    Sponsor organisation address
    Waehringer Guertel 18-20, Vienna, Austria,
    Public contact
    Universitätsklinik für Anästhesie, Medizinische Universität Wien, +43 14040041440, sibylle.pramhas@meduniwien.ac.at
    Scientific contact
    Universitätsklinik für Anästhesie, Medizinische Universität Wien, +43 14040041440, sibylle.pramhas@meduniwien.ac.at
    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 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Mar 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Mar 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Objective/Hypothesis To evaluate the efficacy of cannabidiol in reducing pain due to knee osteoarthritis, as compared to placebo. Efficacy will be evaluated using the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain score.
    Protection of trial subjects
    Informed consent of subjects Following comprehensive instruction regarding the nature, significance, impact and risks of this clinical trial, the patient must give written consent to participation in the study. During the instruction the trial participants are to be made aware of the fact that they can withdraw their consent – without giving reasons – at any time without their further medical care being influenced in any way. In addition to the comprehensive instructions given to the trial participants by the Investigator, the trial participants also receive a written patient information sheet in comprehensible language, explaining the nature and purpose of the study and its progress. The patients must agree to the possibility of study-related data being passed on to relevant authorities. The patients must be informed in detail of their obligations in relation to the trial participants insurance in order not to jeopardize insurance cover. Acknowledgement / approval of the study The Investigator (or a designated CRO) will submit this protocol and any related document provided to the subject (such as subject information used to obtain informed consent) to an Ethics Committee (EC) or Institutional Review Board (IRB). Approval from the committee must be obtained before starting the study. The clinical trial shall be performed in full compliance with the legal regulations according to the Drug Law (AMG - Arzneimittelgesetz) of the Republic of Austria. An application must also be submitted to the Austrian Competent Authorities (Bundesamt für Sicherheit im Gesundheitswesen (BASG) represented by the Agency for Health and Food Safety (AGES Medizinmarktaufsicht) and registered to the European Clinical Trial Database (EudraCT) using the required forms. The timelines for (silent) approval set by national law must be followed before starting the study.
    Background therapy
    		 Parcetamol 3g per die
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 86
    Worldwide total number of subjects
    86
    EEA total number of subjects
    86
    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)
    56
    From 65 to 84 years
    28
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment was conducted from October 1, 2020 to December 16, 2021. Patients were recruited at the Outpatient Clinic of the Department of Special Anaesthesia and Pain Therapy at the Medical University of Vienna, by advertisement in news print and via social media platforms.

    Pre-assignment
    Screening details
    		 Patients aged over 18–98 years with chronic knee pain were eligible. Patients were required to score ≥5 on the pain subscale of the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Patients also had to fulfill the ACR clinical criteria for KOA

    Period 1
    Period 1 title
    Treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Study medication for the entire study period was uniformly packaged and numbered by Hubertus Pharmacy (Spittal/Drau, Austria) that was not otherwise involved in the study. All study medication was delivered to Outpatient Clinic of the Department of Special Anaesthesia and Pain Therapy at the Medical University of Vienna prior to the initiation of the study in a single batch. Participants were randomized to receive a medication number.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cannabidiol
    Arm description
    		 Hemp-derived CBD (purity >99,8%) was extracted by BioSynthesis Pharma Group (BSPG) Ltd., Sandwich, UK, then imported and formulated into capsules by the BSPG subsidiary Trigal Pharma GmbH, Austria. Cap-sules containing CBD (200 mg/capsule). Patients in CBD arm received 600mg per die (200mg-200mg-200mg)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CBD
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    200mg CBD/capsule 600mg per die (1-1-1)

    Arm title
    		 Placebo
    Arm description
    		 Ingredients: Fat, Ascorbyl Pamitate (E304), gelatine capsules (gelatine, titandioxide and/or other approved food colouring) Manufacturer: Hubertus Apotheke, Spital/Drau, Austria
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    3 per die (1-1-1)

    Number of subjects in period 1
    		Cannabidiol Placebo
    Started
    43
    43
    Completed
    27
    31
    Not completed
    16
    12
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    9
    5
         Lost to follow-up
    2
    1
         Lack of efficacy
    4
    1
         Protocol deviation
    -
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 Hemp-derived CBD (purity >99,8%) was extracted by BioSynthesis Pharma Group (BSPG) Ltd., Sandwich, UK, then imported and formulated into capsules by the BSPG subsidiary Trigal Pharma GmbH, Austria. Cap-sules containing CBD (200 mg/capsule). Patients in CBD arm received 600mg per die (200mg-200mg-200mg)

    Reporting group title
    Placebo
    Reporting group description
    		 Ingredients: Fat, Ascorbyl Pamitate (E304), gelatine capsules (gelatine, titandioxide and/or other approved food colouring) Manufacturer: Hubertus Apotheke, Spital/Drau, Austria

    Reporting group values
    		 Cannabidiol Placebo Total
    Number of subjects
    		 43 43 86
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 34 23 57
        From 65-84 years
    		 8 19 27
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 60.0 (55.0 to 65.0) 65 (56 to 73) -
    Gender categorical
    Units: Subjects
        Female
    		 30 30 60
        Male
    		 13 13 26
    Subject analysis sets

    Subject analysis set title
    CBD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CBD-Treatment

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis sets values
    		 CBD Placebo
    Number of subjects
    43
    43
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    34
    23
        From 65-84 years
    8
    19
        85 years and over
    1
    1
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    60.0 (55.0 to 65.0)
    65.0 (56.0 to 73)
    Gender categorical
    Units: Subjects
        Female
    30
    30
        Male
    13
    13

    End points

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    End points reporting groups
    Reporting group title
    Cannabidiol
    Reporting group description
    		 Hemp-derived CBD (purity >99,8%) was extracted by BioSynthesis Pharma Group (BSPG) Ltd., Sandwich, UK, then imported and formulated into capsules by the BSPG subsidiary Trigal Pharma GmbH, Austria. Cap-sules containing CBD (200 mg/capsule). Patients in CBD arm received 600mg per die (200mg-200mg-200mg)

    Reporting group title
    Placebo
    Reporting group description
    		 Ingredients: Fat, Ascorbyl Pamitate (E304), gelatine capsules (gelatine, titandioxide and/or other approved food colouring) Manufacturer: Hubertus Apotheke, Spital/Drau, Austria

    Subject analysis set title
    CBD
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    CBD-Treatment

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Primary: Change in WOMAC pain subscale score from baseline

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    End point title
    		 Change in WOMAC pain subscale score from baseline
    End point description
    End point type
    Primary
    End point timeframe
    8 weeks
    End point values
    		 Cannabidiol Placebo
    Number of subjects analysed
    43
    43
    Units: Scale 1-10
        median (inter-quartile range (Q1-Q3))
    2.5 (1.8 to 3.3)
    2.4 (1.7 to 3.2)
    Statistical analysis title
    		 analysis of covariance model
    Statistical analysis description
    The primary endpoint was analyzed using an analysis of covariance model with change from baseline to week 8 as dependent variable and randomization group,baseline score of WOMAC Pain and stratification variables as independent variables; least-squares means from this model and their group differences are re- ported with 95% confidence intervals (CI). Residual distributions were successfully checked for approximate normal distribution and potentially influential observations tions.
    Comparison groups
    Cannabidiol v Placebo
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From the start to the end
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Frequency threshold for reporting non-serious adverse events: 0%
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The template requires that number of subjects per reporting group that experienced a non-serious adverse events be given. However we reported total frequency of non-serious adverse per reporting group in our study. CBD: 39 subjects at least one AE; Placebo 36 subjects at least one AE Frequencies: CBD Placebo Diarrhea 19 20 Elevation of ASAT, ALAT, gamma-GT 15 5 Abdominal pain 14 11 Fatigue 14 1

    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? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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