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

• Register: EUCTR
• Last refreshed on: 5 July 2021
• Main ID: EUCTR2017-003574-13-DK
• Date of registration: 08/03/2018
• Prospective Registration: Yes
• Primary sponsor: Aalborg university hospital dept. of rheumatology
• Public title: Medical cannabis for the treatment of pain in patients with hand osteoarthritis and psoriatic arthritis.
• Scientific title: The NordCAN study: Cannabis treatment in hand osteoarthritis and psoriatic arthritis. A randomized, double-blind placebo controlled study - NordCAN
• Date of first enrolment: 08/03/2018
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003574-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Jonathan Vela MD.
• Affiliation: Dept. of rheumatology Aalborg

• Name: Jonathan Vela MD.
• Affiliation: Dept. of rheumatology Aalborg

Key inclusion & exclusion 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:
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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

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

Primary end point(s): Changes in VAS pain during the last 24 hours from baseline to 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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12-24weeks

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.

Secondary ID(s)

020683

Source(s) of Monetary Support

Forskningenshus uddannelse og innovation

Region Nordjyllands Sundhedsvidenskabelige Forskningsfond

Aalborg University

Aalborg University Hospital dept. of reumatology

Ethics review

Status: Approved
Approval date: 31/10/2017
Contact: