Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Growth Disorder
About this trial
This is an interventional treatment trial for Growth Disorder
Eligibility Criteria
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.
Sites / Locations
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.