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OpenTrials
Completed

NCT Number: NCT00262249

Effect of Growth Hormone in Children With Growth Hormone Deficiency

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.

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Key information

Conditions

Growth Hormone Disorder Growth Disorder Growth Disorders Growth Hormone Deficiency in Children Idiopathic Short Stature Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Change in height standard deviation score

    Time frame: 24 month

Secondary outcomes

  1. IGF-I

  2. IGFBP-3

  3. free IGF-I

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Dec 6, 2005
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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