临床试验/NCT01734447

NCT01734447已完成4 期

Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 57 人开始时间: 2000年4月30日最近更新: 2017年2月28日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 57
试验地点: 1
主要终点: Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

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

性别: All
接受健康志愿者: 否

入选标准

•Patients born with IUGR enrolled in trial GHRETARD/F/1/F
•Bone age below 14 years in boys and 12 years in girls

排除标准

•Bone age above 14 years in boys and 12 years in girls

研究组 & 干预措施

1.2, continuous treatment

Experimental

干预措施: somatropin (Drug)

1.2, non-continuous treatment

Experimental

干预措施: somatropin (Drug)

2.4, non-continuous treatment

Experimental

干预措施: somatropin (Drug)

结局指标

主要结局

Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

次要结局

Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Pubertal development, assessed according to Tanner method
Height velocity
Final height
Number of Adverse Events

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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