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临床试验/NCT00262249
NCT00262249已完成3 期

Effect of Growth Hormone in Children With Growth Hormone Deficiency and Idiopathic Short Stature

Novo Nordisk A/S41 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2000年8月最近更新:
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适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
173
试验地点
41
主要终点
Change in height standard deviation score
研究概览研究设计入排标准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 the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.

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 15 Years（Child）
性别
All
接受健康志愿者
否

入选标准

  • •Clinically suspected GHD
  • •Height < -2.0 SDS
  • •Serum IGF-I less than or equal to -1.0 SDS
  • •Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
  • •Puberty Tanner Stage I

排除标准

  • •Previous use of growth hormone
  • •Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
  • •Intrauterine growth retardation: birth weight < 3rd percentile.
  • •Administration of other growth-altering medications.
  • •Evidence of any malignancy or intracranial tumors.

结局指标

主要结局

Change in height standard deviation score

时间窗: 24 month

次要结局

  • free IGF-I
  • IGF-I
  • IGFBP-3

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (41)

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