NCT00191165

Efficacy and Safety of a High Dosage Compared to the Label Dosage of Somatropin in Early Pubertal Stage Children With Growth Hormone Deficiency

Efficacy and Safety of a High Dosage Compared to the Label Dosage of Humatrope in Early Pubertal Stage Children With Growth Hormone Deficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, randomized, controlled, open-label, phase III study comparing the effects of two different dosages of somatropin treatment (in-label or doubled) after 12 and 24 months of treatment, on height velocity in early pubertal children with growth hormone deficiency (GHD). The study will be conducted in Italy. Approximately 26 subjects will participate in this study, distributed as 13 in the in-label dosage group (group A) and 13 in the doubled dosage group (group B).

Conditions

• Growth Hormone Deficiency

Interventions

Type	Name	Description
DRUG	Somatropin	Doubled dosage with respect to the pre-enrollment (in-label) dosage
DRUG	Somatropin	In-label dosage

Timeline

• Start date: 2004-03-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2005-09-19
• Last updated: 2009-06-10
• Results posted: 2009-06-08

Locations

10 sites across 1 country: Italy