NCT00396097

Individualized, Target-Driven Treatment Of Children With Idiopathic Short Stature

A Four Year Open Label Multi Center Randomized Two Arm Study Of Genotropin In Idiopathic Short Stature Patients: Comparing An Individualized, Target Driven Treatment Regimen To Standard Dosing Of Genotropin

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that an individualized, formula-based Genotropin regimen for children with Idiopathic Short Stature will lead to a targeted height gain (to reach the target of 10th percentile (%), or -1.3 SDS) during 24 months of treatment. The endpoint at 4 years is to explore treatment efficiency over four years of two formula-based dose regimens (sub-arms) compared to standard treatment

Conditions

• Idiopathic Short Stature

Interventions

Type	Name	Description
DRUG	Genotropin	Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.
DRUG	Genotropin	Compare daily injections of formula-based HGH treatment to daily injections of standard HGH treatment in subjects with Idiopathic Short Stature over 24 months period followed by an exploratory 24 months period.

Timeline

• Start date: 2006-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2006-11-06
• Last updated: 2016-04-05
• Results posted: 2013-11-13

Locations

43 sites across 1 country: United States