CTRI/2009/091/001044已完成2 期
A Multi-center, Randomized, Double Blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults With a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation With an Intramedullary Nail
Amgen Technology Pvt Ltd0 个研究点目标入组 400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
入选标准
- •Inclusion Criteria:
- •Skeletally mature adults, age 18 to 85 years with radiographically closed growth plates
- •Fresh unilateral closed or Gustilo type I or type II open tibial fracture
- •Definitive fracture fixation with reamed (closed and open fractures) or unreamed (open fractures only) intramedullary nailing
排除标准
- •Exclusion Criteria:
- •Major polytrauma or significant axial trauma
- •Associated lower extremity fracture that will delay subjects ability to bear weight beyond the normal time expected for a tibial shaft fracture
- •Use of bone grafts at the time of fracture fixation
- •Pathological fracture or metabolic or bone disease
- •History of symptomatic spinal stenosis or facial nerve paralysis
- •Malignancy within the last 5 years
- •Evidence of the following (currently or within the past 5 years): elevated transaminases, significantly impaired renal function, current hyper- or hypocalcaemia
- •Use of agents affecting bone metabolism
- •Subject refuses to use appropriate methods of contraception
研究者
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