Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
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.