NCT00533377已完成2 期
A Randomized, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of CP-533,536 In Subjects With Closed Fracture Of The Tibial Shaft
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Time to fracture healing compared with placebo
研究概览
简要总结
The purpose of this study is to find out the good and bad effects of an investigational drug called CP-533,536 in patients with closed fracture of the tibial shaft undergoing internal fixation using reamed inter-locked IM nailing procedure
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females 17 years or older with confirmed closure of the tibial epiphyses, with a closed fracture of the tibial diaphysis undergoing treatment with reamed locked IM nailing procedure and the absence of an associated compartment syndrome or vascular injury;
- •Closed tibial fractures Types A, B & C (See OTA fracture classification) can be included.
排除标准
- •Previous fractures of the same tibia that may impact nailing procedure or impaired visibility of current fracture or a history of osteomyelitis;
- •Subjects with any other clinically significant injuries, which may significantly impair weight bearing of the affected limb;
- •Subjects with a fracture gap of >1cm after initial surgery and prior to drug administration;
- •Any other planned invasive or non invasive interventions intended to promote bone healing of the tibial fracture under study are not allowed in the first 24 weeks after treatment.
研究组 & 干预措施
CP-533,536 Dose Level 2
Experimental
干预措施: CP-533, 536 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Standard of Care
Other
干预措施: Standard of Care (Procedure)
CP-533,536 Dose Level 1
Experimental
干预措施: CP-533,536 (Drug)
CP-533,536 Dose Level 3
Experimental
干预措施: CP-533,536 (Drug)
CP-533.536 Dose Level 4
Experimental
干预措施: CP-533,536 (Drug)
结局指标
主要结局
Time to fracture healing compared with placebo
时间窗: 24 weeks
次要结局
- Proportion of subjects who require a secondary intervention to promote fracture healing(48 weeks)
- Impact on the subject's ability to return to normal function, general health status, work productivity, and degree of pain at fracture site compared with placebo and Standard of Care groups(24 weeks)
- Time to fracture healing compared with Standard of Care(24 weeks)
- Proportion of patients healed compared with placebo(16 weeks)
- Time to regular callus formation compared with placebo(24 weeks)
研究者
研究点 (1)
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