Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

Study Overview
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Brief Summary
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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.

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

Conditions
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Growth Hormone Disorder, Growth Hormone Deficiency in Children

Intervention / Treatment
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* Drug: somatropin
* Drug: somatropin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lyophilized<br> | Drug: somatropin<br>* 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<br>|
| Experimental: Liquid<br> | Drug: somatropin<br>* Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (especially injection site reactions) |  |  | 
| Serious adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 (Insulin-like growth factor 1) concentration |  |  | 
| IGFBP-3 (Insulin-like growth factor binding protein 3) concentration |  |  |