Medical cannabis for the treatment of pain in patients with hand osteoarthritis and psoriatic arthritis.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003574-13-DK

Enrollment

160

Registered

2018-03-08

Start date

2018-03-08

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis Hand Osteoarthritis MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 MedDRA version: 20.0 Level: LLT Classification code 10019115 Term: Hand osteoarthritis System Organ Class: 100000004859

Interventions

Product Name: Cannabidiol Product Code: CBD Pharmaceutical Form: Tablet INN or Proposed INN: CBD CAS Number: 13956-29-1 Other descriptive name: CANNABIDIOL Concentration unit: mg milligram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Hand-OA: Patients (18 years or older) with Hand-OA according to the American collage of rheumatology (ACR) criteria (1990) Hand-OA of the phenotype: Nodal, Non-erosive. Ability and willingness to give written informed consent and to meet the requirements of the study protocol. 100mm VAS pain during the last 24 hours over or equal to 30mm PsA: Patients (18 years or older) with PsA according to the classification criteria for psoriatic arthritis CASPAR criteria (2006) Ability and willingness to give written informed consent and to meet the requirements of the study protocol. 100mm VAS pain during the last 24 hours over or equal to 30mm 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 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Hand-Oa and PsA 1. Other known inflammatory rheumatic disease (i.e. Rheumatoid arthritis, gout) 2. Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy) 3. Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs 4. History of psychiatric disease that contraindicates use of medical cannabis treatment (i.e. schizophrenia).

Design outcomes

Primary

Measure	Time frame
Main Objective: 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;Secondary Objective: o Changes is VAS pain during the last 24 hours from baseline to 24 weeks. o Changes in VAS global from baseline to 12 weeks and 24 weeks. o Changes in function scores from baseline to 12 weeks. o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks. o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks (Hand-OA only). o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks. ;Primary end point(s): Changes in VAS pain during the last 24 hours from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: 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;Secondary Objective: o Changes is VAS pain during the last 24 hours from baseline to 24 weeks. o Changes in VAS global from baseline to 12 weeks and 24 weeks. o Changes in function scores from baseline to 12 weeks. o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks. o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks (Hand-OA only). o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks. ;Primary end point(s): Changes in VAS pain during the last 24 hours from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): o Changes is VAS pain during the last 24 hours from baseline to 24 weeks. o Changes in VAS global from baseline to 12 weeks and 24 weeks. o Changes in function scores from baseline to 12 and 24 weeks. o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks. o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks*. o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks and 24 weeks will be made. ;Timepoint(s) of evaluation of this end point: 12-24weeks	—

Measure

Time frame

Secondary end point(s): o Changes is VAS pain during the last 24 hours from baseline to 24 weeks. o Changes in VAS global from baseline to 12 weeks and 24 weeks. o Changes in function scores from baseline to 12 and 24 weeks. o Changes in central pain mechanisms measured with quantitative sensory testing from baseline to 12 weeks and 24 weeks. o Changes in grip and pinch strength from baseline to 12 weeks* and 24 weeks*. o Inflammatory and joint degenerative biomarkers will be measured and comparison between baseline and 12 weeks and 24 weeks will be made. ;Timepoint(s) of evaluation of this end point: 12-24weeks

—

Countries

Denmark

Contacts

Public ContactJonathan Vela MD.

Dept. of rheumatology Aalborg

j.vela@rn.dk+4597664018

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026