EUCTR2020-002803-20-DK进行中（未招募）1 期
Colchicine treatment for patients with hand osteoarthritis: A randomised, placebo-controlled trial - COLOR
Parker Instituttet0 个研究点目标入组 100 人开始时间: 2020年6月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •An individual will be eligible for study participation if he/she meets the following criteria:
- •1.Age =18 years.
- •2.Hand OA according to the ACR criteria above.
- •3.Hand OA finger pain: Pain at rest =40 mm on VAS (0 to 100 mm range).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •A participant will be excluded from the study if he/she meets any of the following criteria listed below. Some exclusion criteria require a blood sample, please see section Visit 2: Screening visit”. Known diseases will be based on diagnosis registered in the participants health journal. If an exclusion diagnose is suspected necessary diagnostics will be performed before inclusion in the study.
- •Comorbidities
- •1.Other known medical disease that may affect joints, e.g. RA, gout, PsA
- •2.Positive anti-cyclic citrullinated peptide (>10 kU/L)
- •3.Known cutaneous deposition diseases (e.g. amyloidosis or porphyria).
- •4.Known blood dyscrasias and coagulation disorders
- •5.Known malignancy (except successfully treated squamous or basal cell skin carcinoma)
- •6.Elevated alanine transaminase (>45 U/L females, >70 U/L for males)
- •7.Creatinine clearance =60 ml/min
- •8.Elevated creatine kinase (>210 U/L females, >280 U/L for males)
- •9.Known allergies towards the interventions
- •10.Drug or alcohol abuse in the last year
- •11.Generalised pain syndromes such as fibromyalgia
- •12.Current reflux
- •13.Current or recurrent diarrhoeal illnesses
- •14.Current abdominal pain
- •15.Known peripheral neuropathies
- •16.Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as e.g. psychiatric disorders.
- •Medical history
- •17.History of hand surgery within 12 months prior enrolment.
- •18.History of arthroplasty or arthrodesis in the hand
- •Management strategies
- •19.Treatment with P-glycoprotein inhibitors and/or cytochrome P450 3A4 (CYP3A4) inhibitors, see section Colchicine safety in drug-drug interactions” and table 7. If potential participants have been treated with these pharmaceuticals previously, treatment must be terminated 5 half-lifes before initiation of study drug.
- •20.Use of systemic corticosteroids equivalent of = 7.5 mg prednisolone daily within 3 months.
- •21.Participation in experimental device or experimental drug study 3 months prior to enrolment.
- •22.Intra-articular treatments or aspirations of any kind of any joint in the hands 3 months before inclusion
- •23. Intra-articular corticosteroids into any joint 1 months before inclusion
- •24.Current use of synthetic or non-synthetic opioids
- •25.Scheduled surgery during study participation
- •26.Planning to start other treatment for hand OA in the study participation period.
- •Reproductive system
- •27.Planned pregnancy within the study period, pregnancy or insufficient anti-conception therapy for female fertile participants. Sufficient anti-conception therapy consists of intra-uterine device (coil) or hormonal anti-conception (birth control pills, implant, intra-uterine system, dermal patch, vaginal ring, or injections).
- •28.Breast-feeding
研究者
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