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Completed

NCT Number: NCT01502124

Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the safety profiles of Norditropin® (lyophilized somatropin) and Norditropin® cartridges (liquid somatropin) in children with growth hormone deficiency.

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Key information

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Age range

3 year–17 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

  • Diagnosis of short stature (height maximum 2 standard deviations of mean for age and gender) or inadequate growth deemed secondary to growth hormone deficiency (GHD)
  • Naïve to growth hormone therapy

Exclusion criteria

  • Known or suspected allergy to the trial product or related products
  • Growth retardation attributable to causes other than GHD. Growth retardation attributable to diabetes mellitus, inborn errors of metabolism, primary bone disease, chromosomal disorders or disease of the genitourinary, cardiopulmonary, gastrointestinal or central nervous system; bone marrow transplantation or any syndrome known to give short stature (examples are: Prader-Willi Syndrome, Russell-Silver Syndrome, Turner Syndrome, Noonan Syndrome)
  • Intrauterine growth retardation: birth weight below 3rd percentile, adjusted for gestational age
  • Pregnancy or the intention to become pregnant
  • Breast-feeding
  • Administration of other growth-altering medication

Treatment and study plan

Somatropin

Drug

Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists

Primary outcomes

  1. Adverse events (especially injection site reactions)

  2. Serious adverse events

Secondary outcomes

  1. IGF-1 (Insulin-like growth factor 1) concentration

  2. IGFBP-3 (Insulin-like growth factor binding protein 3) concentration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Norditropin® and Norditropin® Cartridges: An Open-Label, Randomized, Comparative Safety and Efficacy Trial in Children With Growth Hormone Deficiency

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Dec 30, 2011
Registry last updated
Feb 28, 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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