Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01502124

Enrollment

Registered

2011-12-30

Start date

2001-05-08

Completion date

2003-03-05

Last updated

2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Hormone Deficiency in Children, Growth Hormone Disorder

Brief summary

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.

Interventions

DRUGsomatropin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Adverse events (especially injection site reactions)	—
Serious adverse events	—

Secondary

Measure	Time frame
IGF-1 (Insulin-like growth factor 1) concentration	—
IGFBP-3 (Insulin-like growth factor binding protein 3) concentration	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026