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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693833
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : July 7, 2021
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Jonathan Vela, Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE October 1, 2018
First Posted Date  ICMJE October 3, 2018
Last Update Posted Date July 7, 2021
Actual Study Start Date  ICMJE November 28, 2018
Actual Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
VAS pain during the last 24 hours [ Time Frame: Change from baseline to 12 weeks ]
Measure with a 100mm Visual Analogie Scale (VAS)
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2018)
VAS pain during the last 24 hours [ Time Frame: Change from 12 to 24 weeks ]
Measure with a 100mm Visual Analogie Scale (VAS)
Current Other Pre-specified Outcome Measures
 (submitted: July 16, 2020)
  • Patients experiencing adverse events [ Time Frame: 24 weeks ]
    Percentage of patients experiencing adverse events in placebo and intervention group
  • Characterization of serious adverse events [ Time Frame: 24 weeks ]
    Description of which serious adverse events where experience in each group
  • 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.
  • 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
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.
Official Title  ICMJE CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
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.
Detailed Description

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.

Aim: To assess the effect of CBD on visual analogue scale pain measurements at 12 weeks compared with placebo.

Patients and controls: Patients with Hand-OA or PsA and VASpain during the last 24hours of 30mm or more.

Primary outcome: Changes in VAS pain during the last 24 hours from baseline to 12 weeks. Measured with a 100mm VAS from the most symptomatic hand (Hand-OA) or joint (PsA).

Safety outcomes

  1. Percentage of patients experiencing adverse events (AE)
  2. A characterization of serious adverse events (SAE)

Exploratory outcomes

  1. Difference in VAS-pain at the 24-week follow-up visit between the intervention and placebo group.
  2. Correlation between baseline quantitative sensory testing (QST) and treatment effect after 12 weeks.
  3. Difference in QST change between the intervention and placebo group after 12 weeks of treatment.
  4. Correlation between baseline psychosocial parameters, patient reported outcomes (PROMs) and treatment effect.
  5. Difference in changes of the psychosocial parameters and PROMs between the intervention and control group after 12 weeks of treatment

Intervention: 10mg 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.

The medicine and placebo will be delivered and produced by Glostrup pharmacy.

Examination programme: All participants will receive a full medical interview and a physical examination which includes auscultation, blood pressure, heart rate and saturation measurements and BMI calculation. All participants will have blood drawn for later examination for markers of inflammation and degeneration. All participants will go through Quantitative Sensory Testing (QST). QST covers a wide range of different examinations techniques used to assess the functional status of the somatosensory system. In the present study pressure algometry and cuff algometry will be performed.

Pain phenotyping: Participants will answer a series of questionnaires related to the pain experience to assess: Anxiety and depression (the hospital anxiety and depression scale), pain catastrophizing (the pain catastrophizing scale), pain description (The short form McGill questionnaire and pain detect questionnaire), sleep quality (Pittsburgh sleep quality index) and a Widespread Pain Assessment questionnaire and the Symptom Severity Index. To assess function and quality of life the Short form 36 and Health assessment questionnaire will be used.

Patients with PsA: Will receive an examination for disease specific tests including: joint tenderness and swelling using the EULAR66/68 regiment, dactylitis evaluation using Leeds dactylitis index basic, skin involvement using the psoriasis area and severity index and nail psoriasis via nail psoriasis severity index.

Patients with Hand-OA: Will receive the following disease specific examinations evaluation of tender and swollen joints of the hands and wrists. Grip and pinch strength measurements using a hand-held dynamometer and the functional index of hand-osteoarthritis.

The trial consists of a screening visit, a baseline visit where the patient will undergo randomization, a phone consultation after 4 weeks a blood and urin sample after 6 weeks. and an end of trial visit at week 12. Patients will be invited to a follow-up visit at week 24.

Patients will be asked for adverse events at each visit and these are recorded in the eCRF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psoriatic Arthritis
  • Hand Osteoarthritis
Intervention  ICMJE
  • Drug: Cannabidiol
    Cannabidiol (CBD) tablets of 10mg each
    Other Name: CBD
  • Drug: Placebo Oral Tablet
    Oral Placebo tablets of 10mg each
    Other Name: Oral Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Cannabidiol
  • 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.
    Intervention: Drug: Placebo Oral Tablet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2021)
136
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2018)
180
Actual Study Completion Date  ICMJE June 1, 2021
Actual Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03693833
Other Study ID Numbers  ICMJE NordCAN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jonathan Vela, Aalborg University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Aalborg University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Aalborg University
Investigators  ICMJE
Principal Investigator: Jonathan Vela Dept. of rheumatology Aalborg University Hospital
PRS Account Aalborg University Hospital
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP