NCT00161629已完成1 期
A Phase 1 Dose-Escalating, Double-Blind, Placebo-Controlled, Multicenter, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy for Closed Distal Radius Fractures
Wyeth is now a wholly owned subsidiary of Pfizer7 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2005年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
研究概览
简要总结
To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50 to 80 years of age; alert and oriented to person, place, and time.
- •Acute, closed distal radius fractures (within 4 cm of the tip of the radial styloid process), classified according to AO/ASIF as either A2 or A3 (extra-articular) or C1 or C2 (intra-articular) fractures.
- •Closed fracture reduction and definitive fracture fixation performed within 7 days after injury by means of external skeletal and/or percutaneous pin fixation. Note: fractures that are initially treated by closed reduction and casting, then converted to external or percutaneous pin fixation for definitive fracture fixation within 7 days after injury are eligible for the study.
- •Other inclusion applies.
排除标准
- •Other fractures of the ipsilateral upper extremity (except for ulnar styloid fractures) or the contralateral upper extremity (except for previously healed fractures without residual functional deficit).
- •Fracture fixation by other means (eg, plate and screw fixation).
- •Planned treatment for the fracture includes any procedure to promote fracture healing (eg, open reduction internal fixation, bone grafting, non-invasive modalities such as ultrasound, electrical stimulation, etc). Note: After 12 weeks have elapsed since administration of the treatment assignment, unanticipated procedures to promote fracture healing are permitted as clinically indicated.
- •Other exclusion applies.
结局指标
主要结局
Determine the safety of administering rhBMP-2/CPM to subjects with distal radius fractures that require surgical fixation.
次要结局
- Feasibility of the test article injection procedure and localization of the test article relative to the distal radius fracture site.
研究者
研究点 (7)
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