NCT01697644

Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Growth Hormone Treatment of Children After Intrauterine Growth Retardation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe. The aim of this trial is to assess and compare the efficacy and safety of two dose levels of somatropin over a long period (till final height is reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial) and GHRETARD/BPD/20/NL (a 2-year extension trial).

Conditions

• Foetal Growth Problem
• Small for Gestational Age

Interventions

Type	Name	Description
DRUG	somatropin	3 IU/m\^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
DRUG	somatropin	3 IU/m\^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily

Timeline

• Start date: 1990-10-01
• Primary completion: 2005-05-01
• Completion: 2005-05-01
• First posted: 2012-10-02
• Last updated: 2017-01-18

Locations

2 sites across 1 country: Netherlands