Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-03-07 @ 2:26 PM
Study NCT ID:
NCT03693833
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2018-10-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis.
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
CBD Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NordCAN
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: