Phase IV Study of Diacerein in Human Hand Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
研究概览
简要总结
Ostearthritis is one of the most common arthritis, affecting more than 30% of aged people world-widely. The disease is characterized by pain and stiffness of the affected joints and is the most common cause of disability in aged people. It commonly affects knee, hip, hand and spine joints. Diacerein is a drug developed specifically for the treatment of osteoarthritis. It has inhibitory effects on interleukin-1 (IL-1) and metalloproteases which are known to play key roles in the pathogenesis of osteoarthritis while exerting no effect on phospholipase A2, cyclooxygenase or lipoxygenase. It showed anti-inflammatory effects on animal models and reduced structural changes in several animal models. Therefore, we investigate the role of diacerein in patients with hand osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages over 40 years-old
- •Conforming to the classification criteria of American College of Rheumatology*
- •More than 1 tender joints
- •Self reported hand pain which is more than 30 mm on the Australian/Canadian Osteoarthritis Hand Index visual analogue scales (VAS) after wash out period of 2 weeks
排除标准
- •Pregnant or lactating women
- •Previous history of hypersensitivity to Diacerein
- •Patients who had taken oral corticosteroid or intraarticular steroid to hand joints within 3 months of enrollment
- •Patients who were injected with hyaluronic acid to hand joints within 6 months of enrollment
- •Patients who underwent surgery in any joints of the hands
- •AST/ALT > 2x upper normal range
- •Serum Cr > 1.4 mg/dl
- •Patients who have severe comorbidities such as severe congestive heart failure or pulmonary disease
- •Patients who took oral anticoagulants.
- •Patients who refuse to sign the consent form
研究组 & 干预措施
1
Diacerein 50mg bid
干预措施: diacerein (Drug)
2
placebo 50mg bid
干预措施: placebo (Drug)
结局指标
主要结局
Australian/Canadian Osteoarthritis Hand Index (AUSCAN) pain score at 4 week point
时间窗: 12 weeks
次要结局
- AUSCAN stiffness score at 4 week point(12wks)
- AUSCAN pain score at 12 week point(12wk)