Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. (NordCAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693833
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Jonathan Vela, Aalborg University Hospital

Brief Summary:
A randomized, placebo-controlled trial with blinded outcome assessments will be conducted to evaluate the efficacy and safety of CBD in patients with Hand-OA and PsA during a 12-week treatment period.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Hand Osteoarthritis Drug: Cannabidiol Drug: Placebo Oral Tablet Phase 2

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
Actual Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Intervention
10mg Cannabidiol (CBD) tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
Drug: Cannabidiol
Cannabidiol (CBD) tablets of 10mg each
Other Name: CBD

Placebo Comparator: Placebo
10mg Placebo Oral tablets once daily for the first two weeks increasing to twice daily for week 3 and 4 if adequate analgesic effect is not attained at week 5 then the dose can be increased to 10mg thrice daily from week 5 and onward.
Drug: Placebo Oral Tablet
Oral Placebo tablets of 10mg each
Other Name: Oral Placebo




Primary Outcome Measures :
  1. VAS pain during the last 24 hours [ Time Frame: Change from baseline to 12 weeks ]
    Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.


Secondary Outcome Measures :
  1. VAS pain during the last 24 hours [ Time Frame: Change from 12 to 24 weeks ]
    Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria Hand-OA:

  • Patients (18 years or more) 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.
  • VAS pain during the last 24 hours 30mm or more
  • Negative pregnancy test (serum HCG) prior to trial start (for women of childbearing potential) and the use of contraception throughout the study period and for 3 months after conclusion of the study period for males and females of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.

Inclusion criteria PsA

  • Patients (18 years or more) with PsA according to the Calcification Criteria for Psoriatic Arthritis (CASPAR) criteria (2006)
  • Ability and willingness to give written informed consent and to meet the requirements of the study protocol.
  • VAS pain during the last 24 hours 30mm or more
  • Negative pregnancy test (serum human chorionic gonadotropin (HCG)) prior to trial start and the use of contraception throughout the study period and for 1 month after conclusion of the study period for women of childbearing potential. The forms of contraception include: intrauterine device (IUD) and hormonal contraceptives (contraceptive pill, implant, patch or injection or vaginal ring). Sterile and non-fertile participants do not have to use contraception. Sterile or non-fertile is defined as having undergone surgical sterilization (vasectomy / bilateral tubectomy, hysterectomy or bilateral oophorectomy) or post-menopausal status, defined as absence of menstrual period for at least 12 months prior to enrolment.

Exclusion Criteria:

  • Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout)
  • Erosive Hand-OA (One or more erosive joints on plain x-ray)
  • Isolated Hand-OA of the first metacarpal joint or this joint as the most painful*
  • Other known pain condition (i.e. fibromyalgia, Carpel tunnel syndrome, polyneuropathy)
  • Other known disease where exacerbations need to be treated with systemic corticosteroids (i.e. certain types of inflammatory bowel disease) or patients who have received systemic corticosteroid treatment during the last 3 months.
  • Planning pregnancy, pregnant or breastfeeding. (Fertile women will be tested for pregnancy)
  • Planned major surgery or recent major surgery (last 8weeks)
  • Addictive behaviour or previously addictive behaviour defined as abuse of cannabis, opioids or other recreational or pharmaceutical drugs. Determined through patient interview and medical records.
  • Contraindication to medical cannabis (Known allergy to ingredients, history of severe liver or kidney disease, history of schizophrenia or other serious psychiatric disease).
  • Verified malignant disease
  • History of epilepsy or severe cramps
  • History of serious cardiovascular pathology
  • Lacking ability to corporate with the research staff.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693833


Contacts
Layout table for location contacts
Contact: Jonathan Vela 976664018 ext +45 j.vela@rn.dk

Locations
Layout table for location information
Denmark
Department of Rheumatology Aalborg Universityhospital North Recruiting
Aalborg, Denmark, 9000
Contact: Jonathan Vela, MD    97664018 ext +45    j.vela@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
Aalborg University
Investigators
Layout table for investigator information
Principal Investigator: Jonathan Vela Dept. of rheumatology Aalborg University Hospital

Layout table for additonal information
Responsible Party: Jonathan Vela, Jonathan Vela MD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03693833     History of Changes
Other Study ID Numbers: NordCAN
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jonathan Vela, Aalborg University Hospital:
Cannabidiol
Cannabis
Osteoarthritis
Psoriatic arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Osteoarthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Epidiolex
Anticonvulsants