Safety and Efficacy of Somatropin in Children With Growth Hormone Deficiency
Status and phase
Completed
Phase 3
Conditions
Growth Hormone Deficiency in Children
Growth Hormone Disorder
Treatments
Drug: somatropin
Details and patient eligibility
About
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.
Enrollment
78 patients
Sex
All
Ages
3 to 17 years old
Volunteers
No 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
78 participants in 2 patient groups
Lyophilized
Active Comparator group
Treatment:
Drug: somatropin
Drug: somatropin
Liquid
Experimental group
Treatment:
Drug: somatropin
Drug: somatropin
Trial contacts and locations
21
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Data sourced from clinicaltrials.gov
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