NCT01133613已完成1 期
Double-Blind, Randomized, Single Dose Escalation Safety Study of Intraarticular Bone Morphogenic Protein (38A BMP-7) in Subjects With Osteoarthritis (OA) of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
研究概览
简要总结
The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
0.03 mg/ml BMP-7 or placebo via intraarticular knee injection
干预措施: Bone morphogenetic protein 7 (Drug)
Cohort 2
Experimental
0.1 mg/ml BMP-7 or placebo via intraarticular knee injection
干预措施: Bone morphogenetic protein 7 (Drug)
Cohort 3
Experimental
0.3 mg/ml BMP-7 or placebo via intraarticular knee injection
干预措施: Bone morphogenetic protein 7 (Drug)
结局指标
主要结局
Safety (physical examination, vital signs, clinical laboratory measurements, adverse events)
时间窗: Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24
次要结局
- WOMAC pain and function(Baseline, Week 4, Week 8, Week 12, Week 24)
- Patient and physician global VAS(Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24)
- Quality of life measurement (SF-36) and pain medication use(Baseline, Week 4, Week 8, Week 12, Week 24)
研究者
研究点 (2)
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