Growth Disorder
Conditions
Brief summary
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
Interventions
DRUGsomatropin, rDNA origin, for injection
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
Participation in core, blinded phase and ability to be contacted by investigators. For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.
Exclusion criteria
Diabetes mellitus. History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase. Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection. | — |
| Every year: arm span measurements, head circumference measurements, x-ray for bone age, and | — |
| laboratory blood draws. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not applicable for Amendment (g). | — |
Countries
United States
Outcome results
None listed