Growth Hormone Treatment in Short Children Born Small for Date (Genotonorm)

Pfizer0 个研究点目标入组 110 人开始时间: 1990年3月1日最近更新: 2007年5月3日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Pfizer
入组人数: 110
主要终点: Height, height velocity

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The primary objective is to evaluate, if Genotonorm (Genotropin) increases linear growth in short children born SGA. Safety of the drug is a main objective as well. The growth promoting effect of two different dosages is compared. The effect of long-term treatment on final height is evaluated (according to several amendments)

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 7 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Birth length below -2 SD
•Height at start below - 2 Sd

排除标准

•Any endocrine or chronic disease
•Any known syndrome with short stature

结局指标

主要结局

Height, height velocity

次要结局

Side effects

研究者

发起方

Pfizer

申办方类型

Industry

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