NCT00567385已完成4 期
An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Assessment of acceptance
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Growth failure due to growth hormone insufficiency (GHD)
- •Turner syndrome: established diagnosis according to sex chromosome analysis, or
- •Growth retardation in children with chronic renal disorders
排除标准
- •Pregnancy
- •Breast feeding women
- •Suspected or know allergy to trial product
- •Participating in any other trial involving other investigational products within the last 3 months
- •Previous participation in the trial
- •Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
结局指标
主要结局
Assessment of acceptance
时间窗: after 12 weeks of treatment
次要结局
- Safety
- Adverse Events (AE)
- Compliance
研究者
研究点 (2)
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