临床试验/NCT01697644

NCT01697644已完成4 期

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 75 人开始时间: 1990年10月最近更新: 2017年1月18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: 75
试验地点: 1
主要终点: Linear growth (height during childhood)

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 and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

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: Double (Participant, Investigator)

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

•Completion of the GHRETARD/BPD/20/NL trial
•Written informed consent from child and/or parents/guardians before continuation in the extension trial

排除标准

未提供

研究组 & 干预措施

Low dose

Experimental

干预措施: somatropin (Drug)

High dose

Experimental

干预措施: somatropin (Drug)

结局指标

主要结局

Linear growth (height during childhood)

Final height

Bone maturation

Pubertal development

次要结局

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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