NCT01073605

Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation

A Two Years Multicentre Study of Genotropin Treatment of Short Prepubertal Children With Intra-Uterine Growth Retardation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effect of continuous and intermittent administration of Genotonorm on stature in short prepubertal children with intra-uterine growth retardation

Conditions

• Growth Disorders
• Intrauterine Growth Retardation

Interventions

Type	Name	Description
DRUG	Genotonorm	0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
DRUG	Genotonorm	1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
DRUG	Genotonorm	1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)

Timeline

• Start date: 1993-07-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2010-02-23
• Last updated: 2010-11-18
• Results posted: 2010-08-31

Locations

31 sites across 1 country: France