NCT00174187

Treatment With Recombinant Human Growth Hormone (GH) in Children With Short Stature Secondary to a Long Term Corticoid Therapy

Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) in Children With Short Stature Secondary to a Long Term Corticoid Therapy. A Study of Efficacy and Safety.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

* To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy * To assess the effect of a long term treatment with Genotonorm on bone mineralisation * To assess the effect of a long term treatment with Genotonorm on body composition

Detailed description

This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Conditions

• Endocrine System Diseases

Interventions

Type	Name	Description
DRUG	Somatropin	liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Timeline

• Start date: 2000-09-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2005-09-15
• Last updated: 2012-12-04
• Results posted: 2012-12-04

Locations

2 sites across 1 country: France