EUCTR2005-005442-39-AT进行中（未招募）不适用
Randomized controlled trial of prednisolone in the treatment of osteaoarthritis of the hand - BELIOA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- •Age >18 Jahre
- •Obtained written informed consent
- •Osteoarthritis of the hands according to the criteria of the AMerican College of Rheumatology, including patients with bony swelling/overgrowth in at least one proximal or distal interphalangeal joint or one carpo-metacarpal joint.
- •Active disease, defined as pain in the hands =40mm (on a 100mm visual analogue scale).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Current therapy with oral steroids: Prednisolon >10mg/Tag
- •Infections : defined by (a) respective clinical signs and symptoms, or (b) fever >37°C during the past 48h, or (c) leukocytosis >12 G/L.
- •Uncontrolled congestive heart failure: defined as (a) right cardiac failure with peripheral edema, or (b) left cardiac failure with dyspnoe (NYHA II-IV)
- •Diabetes Mellitus: defined by (a) therapy with oral antidiabetics, or (b) therapy with insulin, or (c) abnormal fasting blood glucose levels
- •Insufficianetly controlled hypertension: defined as(a) systolischer blood pressure >160 mmHg, or (b) diastolic blood pressure >90 mmHg
- •GI bleeding or history of GI bleeding
- •Known allergic reactions to non-steroidal anti-rheumatic drugs including naproxen
研究者
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