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    Summary
    EudraCT Number:2019-003591-40
    Sponsor's Protocol Code Number:131082019
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-03-24
    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 ConcernedAustria - BASG
    A.2EudraCT number2019-003591-40
    A.3Full title of the trial
    Efficacy of Cannabidiol in Treatment of Pain due to symptomatic Osteoarthritis of the Knee: A randomized, double-blind, placebo-controlled
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cannabidiol in Treatment of Pain due to Attrition of the Knee Joint
    Cannabidiol zur Behandlung von Knieschmerzen aufgrund von Abnützungserscheinungen
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of Cannabidiol in Knee Osteoarthritis
    A.4.1Sponsor's protocol code number131082019
    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 SponsorMedizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien
    B.5.2Functional name of contact pointUniversitätsklinik für Anästhesie
    B.5.3 Address:
    B.5.3.1Street AddressWähringergürtel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number+4314040041440
    B.5.6E-mailsibylle.pramhas@meduniwien.ac.at
    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.3.4Pharmaceutical form Capsule
    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 INNCannabidiol
    D.3.9.1CAS number 13956-29-1
    D.3.9.2Current sponsor code131082019
    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 number600
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Painful osteoarthritis of the knee
    E.1.1.1Medical condition in easily understood language
    Cannabidiol in Treatment of Pain due to Attrition of the Knee Joint
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    To assess the following in patients with painful knee osteoarthritis
    taking cannabidiol:
    -Change of function in knee osteoarthritis
    -Change of patient global assessment of knee osteoarthritis (PGA-KOA).
    -Change of pain from baseline as compared to placebo measured by the
    Visual Analogue Scale (VAS)
    -Responder rate in terms of change of pain from baseline
    -Safety and efficacy of cannabidiol through monitoring of:
    Adverse events
    Clinical laboratory tests
    Vital signs
    -Health Related Quality of Life Score (SF-36) as compared to placebo
    -6 min walk-test as compared to placebo
    -PainDETECT score as compared to placebo
    -to compare the use of the rescue medication in the placebo and
    treatment arm.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patient must be willing and able to give informed consent for
    participation in the study
    • Age 18-80 years
    • Knee Pain
    WOMAC Pain Subscale ≥ 5 during screening
    • Mean Visual Analogue Scale (VAS) ≥ 5 during 1 week of screening.
    • Fulfilment of the clinical criteria of the American College of
    Rheumatology for knee OA 8
    • X-ray or MRI confirmation of knee osteoarthritis within the previous
    12 months
    • All medications or interventions for pain due to knee osteoarthritis
    must have been stable for two weeks prior to screening and patient is
    willing to maintain a
    stable regimen throughout the study.
    E.4Principal exclusion criteria
    • Current mood disorder (dysthymia, bipolar mood disorder)
    • Major Depression > 12 months (Beck Depression Inventory Score ≥
    18)
    • History of a psychoactive substance use disorder within the preceding
    12 months
    • Major coexisting medical illness (e.g. severe heart failure, pulmonary
    hypertension, renal insufficiency)
    • Glaucoma
    • Acute myocardial infarction
    • Uncontrolled hypertension
    • History of convulsion
    • Pregnancy; women of childbearing age will be required to use
    contraceptives during the duration of the study. Furthermore a
    pregnancy test will be performed prior to the beginning of the study and
    once a month during the study period.
    • Breast feeding
    • Participation in a clinical trial in the 3 weeks preceding the study
    • Allergy to study medication
    • Recent intra-articular corticosteroid or hyaluronic acid injection in the
    knee joint. Patients must be willing to abstain from such interventions
    during the entire study
    • Use of the following medication:
    - opioids except for tramadol,
    - benzodiazepines other than indicated at low doses for sleep disorders
    - NSAID
    • Impaired kidney function (Creatinine > 1.5mg/dl)
    • Patient has significantly impaired hepatic function
    defined as any of the following:
    − Alanine aminotransferase (ALT) or aspartate aminotransferase
    (AST) >5 × upper limit of normal (ULN).
    − ALT or AST >3 × ULN and (total bilirubin [TBL] >2 × ULN
    or international normalized ratio [INR] >1.5).
    − ALT or AST >3 × ULN with the presence of fatigue, nausea, vomiting,
    right upper quadrant pain or tenderness, fever, rash,and/or eosinophilia
    (>5%).
    • Patient is currently using or has in the past used recreational or
    medicinal cannabis or synthetic cannabinoid based medications within 3
    months prior to study entry
    • Patient is unwilling to abstain from using recreational or medicinal
    cannabis, or synthetic cannabinoid based medications during the study
    • Patients who are not able to understand the study measures and are
    not able to complete pain assessment forms.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline (V1 see Table 1) in WOMAC-Pain Index to the
    last week of the treatment phase (V9, see Table 1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 of treatment period
    E.5.2Secondary end point(s)
    • Change from baseline in WOMAC Physical function (V1) during the
    last week of the treatment phase (V9)
    • Change from baseline (V1) in Patient global assessment of Knee
    Osteoarthritis (PGA-KOA) to PGA-KOA during the last week of the
    treatment phase (V9).
    • Use of rescue medication
    • Change from baseline (week 1) VAS-score during the last week of the
    treatment phase (week 9)
    • Weekly mean of visual analogue scale (VAS)-score in the last week of
    the treatment period
    • Number of patients considered treatment responders defined as
    those with a ≥30% reduction in mean VAS-Score from baseline to the
    last week of treatment
    • Number of patients considered treatment responders defined as
    those with a ≥50% reduction in mean VAS-Score from baseline to the
    last week of treatment
    • Safety assessment (Frequency of AE; changes in laboratory
    parameters; vital signs)
    • Changes from baseline in quality of life as assessed by the SF-36
    Questionaire
    • Changes from baseline in 6 min walk-test
    • Changes from baseline in PainDETECT score
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8 of treatment period
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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: 66
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state86
    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)
    Treament of patients will continue at our out-patient clinic for Pain Therapy at the Medical University of Vienna
    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 Decision2020-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-29
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