Painful osteoarthritis of the knee
Conditions
Interventions
Product Name: Cannabidiol
Pharmaceutical Form: Capsule
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Current Sponsor code: 131082019
Other descriptive name: CANNABIDIOL
Concentration unit: m
Sponsors
Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 66 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary 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);Timepoint(s) of evaluation of this end point: Week 8 of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: Week 8 of treatment period | — |
Countries
Austria
Contacts
Public ContactUniversitätsklinik für Anästhesie
Medizinische Universität Wien
Outcome results
None listed