Efficacy of Cannabidiol in Knee Osteoarthritis

NCT04607603 | Completed Phase 4 DMC

• 1 other identifier: Version 1.4
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Painful symptomatic osteoarthritis (OA) of the knee is a very common disease, especially in older people (lifetime prevalence 9.5%). Current systemic pharmacological treatment options are limited. Many patients presenting with knee osteoarthritis are of an advanced age and suffer from various co-morbidities. The benefit of the available systemic pharmacological treatment options in these patients can be summarized as uncertain. Therefore, the investigation of new symptomatic systemic pharmacological treatment options for knee OA is relevant. Even in patients without known contraindications, the treatment period with non-steroidal anti-inflammatory drugs should be kept short. It follows that the investigation of new potentially anti-inflammatory substances is of interest in symptomatic OA of the knee. Cannabidiol has anti-inflammatory and analgesic properties in animal models. We therefore propose a randomised, double-blind, placebo-controlled clinical trial to investigate the potential efficacy of cannabidiol in painful symptomatic OA of the knee.

Conditions

Osteo Arthritis Knee; Pain, Joint

Outcome Measures

Primary Outcomes (1)

• WOMAC Pain Score (WOMAC) Pain score

  Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) Pain Score Minimum=0 (best outcome) Maximum=10 (worst outcome)

  Change from baseline in WOMAC-Pain Index to the last week of the treatment phase (Week 8)

Secondary Outcomes (7)

• WOMAC Physical function

  Change from baseline in WOMAC Physical function during the last week of the treatment phase (Week 8)

• Patient global assessment of Knee Osteoarthritis (PGA-KOA)

  Change from baseline in PGA-KOA to PGA-KOA during the last week of the treatment phase (Week 8).

• Use of Rescue Medication

  Use of rescue mediaction during the 8 week treatment period

• Visual Analogue Scale (VAS)

  Change mean 1 week VAS-Score from baseline to the last week of the treatment phase (Week 8)

• Health Related Quality of Life Score (SF-36)

  Change of SF-36 score from baseline to the last week of the treatment phase (Week 8)

Study Arms (2)

Cannabidiol

EXPERIMENTAL

In the Cannabidiol (CBD) arm CBD will be titrated up to 600 mg per die (titration 1 week) in capsules (3 daily doses) and maintained at 600mg per die (3 daily doses) for 7 weeks

Drug: Cannabidiol Oral Product

Placebo

PLACEBO COMPARATOR

In the placebo arm the placebo comparator will be administered in capsules in 3 daily doses

Drug: Placebo

Interventions

Cannabidiol Oral Product DRUG

Cannabidiol is administered in capsules. Each capsule contains 200mg of CBD administered 3 times daily to a total of 600mg per die

Cannabidiol

Placebo DRUG

Placebo will be administered in capsules of identical appearance to CBD capsules in 3 doses per die

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fulfilment of the clinical criteria of the American College of Rheumatology for knee OA 13
• X-ray or MRI confirmation of knee osteoarthritis
• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Anesthesiology and Pain Medicine, Medical University Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Pramhas S, Thalhammer T, Terner S, Pickelsberger D, Gleiss A, Sator S, Kress HG. Oral cannabidiol (CBD) as add-on to paracetamol for painful chronic osteoarthritis of the knee: a randomized, double-blind, placebo-controlled clinical trial. Lancet Reg Health Eur. 2023 Nov 10;35:100777. doi: 10.1016/j.lanepe.2023.100777. eCollection 2023 Dec.

  PMID: 38033459 DERIVED

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blind placebo-controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: October 13, 2020
• Primary Completion: February 17, 2022
• Study Completion: March 29, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

AU (1)