NCT00519844已完成4 期
Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.
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
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children treated for 3 years with Maxomat® because of small for gestational age
- •Postnatal growth failure by the age of 3 years or more
- •No associated growth hormone deficiency
- •Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
- •Bone age no more than 13 years for girls and no more than 15 years for boys
排除标准
- •Known, evolving tumour
- •Hypertrophic cardiomyopathy
- •Hypertension not controlled on maximum therapy
- •Benign intracranial hypertension
- •Known glucose intolerance or known diabetes mellitus
- •Acute or active chronic hepatitis
- •Chronic renal failure
- •Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality
结局指标
主要结局
Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference
时间窗: after 3 months of treatment
次要结局
- Tolerance of the treatment
- Compliance
- Biological (fasting glucose, fasting insulin, liver enzymes)
- Clinical (adverse events)
研究者
研究点 (1)
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