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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00191074
Study type Interventional
Source Eli Lilly and Company
Contact
Status Completed
Phase Phase 3
Start date February 2001
Completion date January 2006

See also
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Completed NCT00001190 - Study of Luteinizing Hormone-Releasing Hormone Analog (LHRHa) in Pubertal Patients With Extreme Short Stature Phase 2
Completed NCT01578135 - French National Registry of Children Born Small for Gestational Age Treated With Somatropin
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Recruiting NCT02769975 - Evaluation of Children With Endocrine and Metabolic-Related Conditions
Completed NCT01778023 - Efficacy and Safety of Recombinant Human Growth Hormone on Height Velocity in Subjects With Idiopathic Short Stature Phase 3
Completed NCT01543867 - Safety and Efficacy of Long-term Somatropin Treatment in Children N/A
Terminated NCT02311322 - Genetic Causes of Growth Disorders
Withdrawn NCT01512095 - Bioequivalence of Two Products (Norditropin® Versus Nutropin AQ®) in Healthy Adult Volunteers Phase 1
Completed NCT00262249 - Effect of Growth Hormone in Children With Growth Hormone Deficiency Phase 3
Completed NCT02428296 - Study of Sirolimus Therapy for Segmental Overgrowth Caused by Somatic PI3K Activation Phase 2
Completed NCT00174421 - Treatment Of Short Stature With Genotropin In Children Born Small For Gestational Age Until Final Height Phase 3