NCT00235079已完成4 期
Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The CORP 2 Trial: COlchicine for Recurrent Pericarditis.
Azienda Sanitaria Locale 3, Torino4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2005年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Recurrence rate at 18 months
研究概览
简要总结
The purpose of the study is to determine whether colchicine is safe and effective in treatment and prevention of recurrent pericarditis after failure of conventional treatment.
详细描述
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data (observational, non-randomized studies without a control group) have shown that the drug may be effective in treatment of the second and subsequent recurrence and the prevention of further recurrences.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the second and subsequent attack of recurrent pericarditis,
- •Age≥ 18 years,
- •Informed consent.
排除标准
- •Suspected neoplastic, tuberculous, or purulent etiology,
- •Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality,
- •serum creatinine>2.5 mg/dl,
- •Serum CK over the upper limit of normality or Known myopathy,
- •Known gastrointestinal or blood disease,
- •Pregnant or lactating women or women not protected by a contraception method,
- •Known hypersensibility to colchicine,
- •Treatment with colchicine at the enrolment.
研究组 & 干预措施
Colchicine
Experimental
Colchicine 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
干预措施: Colchicine (Drug)
Placebo
Placebo Comparator
Placebo 0.5mg BID (>70Kg) or 0.5 once daily for 6 months
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrence rate at 18 months
时间窗: 18 m onths
次要结局
- Symptom persistence at 72 hours, remission rate at 1 week. Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study.(1 week)
研究者
研究点 (4)
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