NCT02000232已完成不适用
Impact of Unapproved Drug Initiative on Colchicine Use
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.
研究概览
简要总结
Measure if FDA regulation of Colchicne in 2009 has resulted in safer use in clinical settings.
Our study will assess the impact of this Initiative on colchicine use and will provide data that supports its continuation and expansion.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Clinical diagnosis of gout
- •Current use of colchicine/colcrys to treat gout
- •Ablility to provide Informed consent
排除标准
- •Inability to provide Informed consent
结局指标
主要结局
Frequency of use of colchicine in an unapproved fashion in contemporary medical proactice.
时间窗: This is an oberservational study and patients will be followed for upto 2 years from enrollment.
We expect to understand the impact of regulatory approach to colchicine preparation and how marketing can affect clinical use patterns in the real world.
次要结局
未报告次要终点
研究者
研究点 (1)
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