A Phase 2, Multicenter, Double-Blind, Randomized, Stratified, Controlled, Efficacy, Safety and Feasibility Study of Recombinant Human Bone Morphogenetic Protein-2 (rhBMP-2)/Calcium Phosphate Matrix (CPM) as an Adjuvant Therapy in Closed Fractures of the Humerus
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 139
- 主要终点
- The primary efficacy variable in this study is radiographic union.
研究概览
简要总结
The primary objective of this study is to assess whether fracture union is accelerated in subjects with humeral fractures (proximal,diaphyseal) treated with conservative therapy (standard of care) and a single dose of rhBMP-2/CPM compared to subjects who receive standard of care alone.
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
- Double (Participant, Investigator)
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
- •Skeletally mature subjects age 18 years or older.
- •Subjects with either a closed proximal humeral fracture or a diaphyseal humeral fracture.
- •Treatment plan that includes only conservative (nonoperative) therapy within 48 hours following injury.
排除标准
- •Shoulder dislocation at the time of injury.
- •Planned procedure(s) at that would stimulate fracture union at the time of application of the initial immobilization device.
- •Fractures located in the distal third of humerus.
研究组 & 干预措施
A
1.0 mg/mL rhBMP-2/CPM + SOC
干预措施: rhBMP-2/CPM (Drug)
B
2.0 mg/mL rhBMP-2/CPM + SOC
干预措施: rhBMP-2/CPM (Drug)
C
Buffer/CPM + SOC
干预措施: rhBMP-2/CPM (Drug)
D
Standard of Care Alone (SOC)
干预措施: rhBMP-2/CPM (Drug)
结局指标
主要结局
The primary efficacy variable in this study is radiographic union.
时间窗: Fracture union is assessed at 4, 6, 8, 10, 12, 16, 26 and 52 week visits. The goal of acceleration of fracture union will be met if median time to radiographic fracture union is decreased by 4 weeks in an active treatment arm compared to SOC alone.
次要结局
未报告次要终点