EUCTR2004-000803-17-LT进行中（未招募）不适用
Prospective, controlled clinical study on the effect of 120 mg depot-methyl-prednisolone compared to placebo on the course of recent onset arthritis - Very early steroid therapy in arthritis - the Stop Arthritis Very Early (SAVE) trial
The SAVE trial group0 个研究点目标入组 400 人开始时间: 2005年11月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •Eligible to the trial are newly referred patients with
- •- arthritis of at least one joint (out of 66 possible joints),
- •- a duration of symptoms of inflammatory arthritis of 16 weeks at most,
- •- no pre-treatment with steroids for this indication
- •- no pre-treatment with a coxib for this indication
- •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
- •Excluded will be:
- •-Patients under 18 yrs.
- •-Patients with joint swelling due to trauma.
- •-Patients with only DIP arthritis.
- •-Patients with suspected or proven septic arthritis or gout.
- •-Patients requiring oral anticoagulant therapy precluding i. m. injections
- •-Patients who are pregnant.
- •-Patients with a contraindication for Paracetamol
- •osevere liver function failure (Child-Pugh >9)
- •osignificantly impaired kidney function (creatinine >1,8 mg/dl)
- •oGilbert-Meulengracht's syndrome
- •-Patients with a contraindication for NSAIDs and/or coxibs:
- •oa history of sulfonamide allergy
- •oactive gastric- or duodenal ulcer or gastrointestinal bleeding
- •oa history of exacerbation of asthma, uticaria, or angioedema following NSAID- or aspirin intake.
- •osevere liver function failure (Child-Pugh >9)
- •osignificantly impaired kidney function (creatinine >1,8 mg/dl)
- •osevere heart failure
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