NCT00254514已完成2 期
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 41
- 主要终点
- Time from surgery until fracture has healed
研究概览
简要总结
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary surgical treatment of tibia fracture using intramedullary nailing
- •Closed fractures: Tscherne Type C1, C2 and C3
- •Open fractures: Gustilo Grade I, II and IIIa
排除标准
- •Open growth plate on X-rays
- •Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 > 32.0
- •Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
- •Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
结局指标
主要结局
Time from surgery until fracture has healed
时间窗: During a 12 month period
次要结局
- Investigator's assessment: fracture healed
- Number of fractures healed
研究者
研究点 (41)
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