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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Endocrine System Diseases

Treatments: Drug: Somatropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174187

A6281016

307-MET-9002-0009

Details and patient eligibility

About

• 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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with juvenile arthritis or nephrotic syndrome
• Before or during puberty

Exclusion criteria

• Diabetes Type 1 and 2
• Endocrine disease, except well substituted hypothyroidism

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Somatropin

Experimental group

Treatment:

Drug: Somatropin