CBS Treatment in Hand Osteoarthritis and Psoriatic Arthritis.
赞助:
Aalborg Universitetshospital
合作者:
信息的提供 (责任方):
Jonathan Vela，Aalborg Universitetshospital
| 追踪信息 | |||
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| 首次提交日期 ICMJE | October 1, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 20, 2018 | ||
| 预计主要完成日期 | October 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
VAS pain during the last 24 hours[ Time Frame: Change from baseline to 12 weeks ] Measure with a 100mm Visual Analogie Scale (VAS) |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | CBS Treatment in Hand Osteoarthritis and Psoriatic Arthritis. | ||
| 正式标题 ICMJE | CBS Treatment in Hand Osteoarthritis and Psoriatic Arthritis. A Randomized, Double-blind Placebo Controlled Study | ||
| 简要概况 | 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. |
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| 详细说明 | 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 nodal non-erosive 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). Secondary outcomes: Changes in VAS pain from 12 to 24 weeks. Changes in each of the pain phenotyping areas from baseline to 12 and 24 weeks. Changes in central pain mechanisms measured with QST from baseline to 12 and 24 weeks. 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 system33. 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 (Pittsburg sleep quality index) and a widespread pain assessment questionnaire. 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. The trial consists of a screening visit, a baseline visit where the patient will undergo randomization, a phone consultation after 5 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. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 2 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
180 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | December 31, 2019 | ||
| 预计主要完成日期 | October 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria Hand-OA: - Patients (18 years or more) with Hand-OA according to the American Collage of Reumatology (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. | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Jonathan Vela，Aalborg Universitetshospital | ||
| 研究赞助商 ICMJE | Aalborg Universitetshospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Aalborg Universitetshospital | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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