NCT01563926已完成3 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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Patient acceptance of the new liquid growth hormone formulation
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent by patient and/or guardian/parents
- •Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
- •Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
- •Patients on growth hormone therapy for at least 6 weeks before entering the trial
排除标准
- •Pregnancy or breast feeding women
- •Suspected or known allergy to trial product
- •Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
- •Participating in any other trial involving other investigational products within the last 3 months
研究组 & 干预措施
Somatropin
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Patient acceptance of the new liquid growth hormone formulation
次要结局
- Number of Serious Adverse Events (SAE)
- Number of Adverse Events (AE)
研究者
研究点 (1)
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