NCT00184691

Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years

Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years. Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin

Timeline

• Start date: 1999-04-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2005-09-16
• Last updated: 2017-01-18

Locations

13 sites across 1 country: Spain