Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

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.

Timeline

Start

2001-02

Primary completion

—

Completion

2006-01

Drugs

Indications

No indication recorded.