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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 : July 17, 2020
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

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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 : November 28, 2018
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : June 30, 2021


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.


Other Outcome Measures:
  1. Patients experiencing adverse events [ Time Frame: 24 weeks ]
    Percentage of patients experiencing adverse events in placebo and intervention group

  2. Characterization of serious adverse events [ Time Frame: 24 weeks ]
    Description of which serious adverse events where experience in each group

  3. Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group. [ Time Frame: at 24week followup ]
    Measure with a 100mm Visual Analogue Scale (VAS) with higher values indicating more pain.

  4. Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks. [ Time Frame: at 12week visit ]
    QST measurements will include pain detection threshold, pain tolerance threshold, temporal summation and conditioned pain modulation

  5. Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect [ Time Frame: at 12 week visit ]
    patient reported outcome includes: Expected effect of treatment is measured using the Stanford expectations scale. Pain catastrophizing thoughts are measured using the Pain catastrophizing scale. Presence of widespread pain is evaluated using the Widespread Pain Index and the Symptom Severity Scale. Sleep quality is evaluated using the Pittsburgh Sleep Quality Index. Presence of anxiety and depression is measured using the Hospital Anxiety and Depression Scale. Furthermore, pain phenotype will be quantified using the Pain Detect Questionnaire and Short Form McGill questionnaire. Quality of life is quantified using the Short form 36 and disability using the Health Assessment Questionnaire Disability Index and Functional index of hand osteoarthritis.

  6. 5. Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment [ Time Frame: at 12 week visit ]
    patient reported outcome includes: Expected effect of treatment is measured using the Stanford expectations scale. Pain catastrophizing thoughts are measured using the Pain catastrophizing scale. Presence of widespread pain is evaluated using the Widespread Pain Index and the Symptom Severity Scale. Sleep quality is evaluated using the Pittsburgh Sleep Quality Index. Presence of anxiety and depression is measured using the Hospital Anxiety and Depression Scale. Furthermore, pain phenotype will be quantified using the Pain Detect Questionnaire and Short Form McGill questionnaire. Quality of life is quantified using the Short form 36 and disability using the Health Assessment Questionnaire Disability Index and Functional index of hand osteoarthritis.



Information from the National Library of Medicine

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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)
  • 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:

  • Concurrent diagnosis of chronic regional pain syndrome or neuropathy
  • Other known inflammatory rheumatic disease (i.e. rheumatoid arthritis, gout not in remission)
  • 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.
  • Indication for changing the anti-inflammatory treatment regimen at baseline (PsA only).

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
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Contact: Jonathan Vela 976664018 ext +45 j.vela@rn.dk

Locations
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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
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Principal Investigator: Jonathan Vela Dept. of rheumatology Aalborg University Hospital
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Responsible Party: Jonathan Vela, Jonathan Vela MD, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03693833    
Other Study ID Numbers: NordCAN
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020

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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:
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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