NCT01502124已完成3 期
Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone 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
- 78
- 试验地点
- 1
- 主要终点
- Serious adverse events
研究概览
简要总结
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.
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
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
- •Naïve to growth hormone therapy
排除标准
- •Known or suspected allergy to the trial product or related products
- •Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
- •Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
- •Pregnancy or the intention to become pregnant
- •Breast-feeding
- •Administration of other growth-altering medication
研究组 & 干预措施
Lyophilized
Active Comparator
干预措施: somatropin (Drug)
Liquid
Experimental
干预措施: somatropin (Drug)
结局指标
主要结局
Serious adverse events
Adverse events (especially injection site reactions)
次要结局
- IGFBP-3 (Insulin-like growth factor binding protein 3) concentration
- IGF-1 (Insulin-like growth factor 1) concentration
研究者
研究点 (1)
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