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Completed

NCT Number: NCT00102817

Somatropin (Norditropin) in Insulin-like Growth Factor (IGF) Deficient Children

This trial is conducted in the United States of America (USA). This is a 12 month study to determine if Norditropin is safe and effective in children with IGF deficiency.

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Key information

Conditions

Growth Hormone Disorder Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases Pituitary Dwarfism

Age range

3 year–13 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

  • Ages 3-15
  • Presence of growth failure indicated by height standard deviation score less than equal to -2
  • Body mass index greater than or equal to 25th percentile for height age
  • IGF concentration less than or equal to 33rd percentile

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Change in height standard deviation score

    Time frame: 12 months

Secondary outcomes

  1. 12 months change in height standard deviation score adjusted for parent height z-score

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Somatropin (Norditropin) in Children With Growth Failure Associated With ICF Deficiency.

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Feb 2, 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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