NCT01444729已完成不适用
A Non-Interventional Post Approval Commitment Study To Evaluate The Outcomes Of The Various Treatment Options For Dupuytren's Contracture
Endo Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 305
- 试验地点
- 1
- 主要终点
- treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
研究概览
简要总结
An agreement has been made to conduct a post-approval commitment study that provides supplementary information relating to the use of Xiapex® as well as other non-pharmacological treatments for Dupuytren's contracture by health care professionals in a real world clinical setting.
详细描述
phase 4, open label, multi-center, prospective non-interventional descriptive
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Adults with a palpable cord eligible for the treatment of Dupuytren's contracture
排除标准
- 未提供
研究组 & 干预措施
xiapex
Subject treated with Xiapex
干预措施: Xiapex (Drug)
Surgery
Fasciotomy or fasciectomy
干预措施: surgery (Procedure)
结局指标
主要结局
treatment satisfaction using the Patient or Physician Global Assessment and Satisfaction questionnaires
时间窗: an expected average of 5 weeks
clinical treatment success as assessed by goniometry
时间窗: an expected average of 5 weeks
次要结局
- Treatment option as determined by treating physician in consultation with patient(at day 1)
研究者
研究点 (1)
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