临床试验/NCT00452491

NCT00452491已完成3 期

A Cohort of Pre-pubertal Children for the Study of Optimization of Methods of Administration of the Biosynthetic Growth Hormone MAXOMAT ® in the Treatment of Severe Early Onset Intrauterine Growth Retardation

Sanofi1 个研究点分布在 1 个国家目标入组 306 人开始时间: 1993年5月最近更新: 2010年10月5日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Sanofi
入组人数: 306
试验地点: 1
主要终点: Efficacy data : measurement of height

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

To test for equivalence in terms of catch-up growth between the 2 therapeutic regimens
To specify the best period of treatment
To assess the efficacy of treatment based on final adult height of these children

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 11 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Pre-pubertal children of either sex presenting with severe early onset intrauterine growth retardation (I.U.G.R.)
•Height Less Than or Equal to -3 SD

排除标准

•Age less than 3 years
•The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

研究组 & 干预措施

1

Experimental

干预措施: somatropin (Drug)

2

Active Comparator

干预措施: somatropin (Drug)

结局指标

主要结局

Efficacy data : measurement of height

时间窗: at trimestrial visit

次要结局

laboratory test assessment and evaluation of bone age(at every other visit)
measurement of anti-GH and anti-ECP antibodies(one visit out of four)
Tolerance data : undesirable events(throughout the study)

研究者

发起方

Sanofi

申办方类型

Industry

研究点 (1)

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