NCT00174291

Prevention of Growth Retardation by Early Treatment With Growth Hormone (GH) in Children With CJA Treated by Corticosteroid Therapy

Prevention of Retarded Growth by Early Treatment With Recombinant Human Growth Factor Genotonorm (Registered) in Children With Systemic Forms of Chronic Juvenile Arthritis Receiving Long-term Corticosteroid Therapy. Extension of the Study Beyond Three Years

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 4 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

* To evaluate the effect of increasing the growth hormone dose on the statural response * To assess the value of early treatment during the course of arthritic disease by comparing the height acquired in the medium term by children in the two groups: treated from the start, or 1 year to 15 months after the diagnosis of CJA, or treated for 4 years after the diagnosis

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 to final height Maximum Dosage: 50 µg/kg/day

Timeline

• Start date: 2002-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2005-09-15
• Last updated: 2012-12-04
• Results posted: 2012-12-04

Locations

1 site across 1 country: France