Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation

Phase 4

Completed

• Conditions: Foetal Growth Problem; Small for Gestational Age
• Interventions: Drug: somatropin

• Registration Number: NCT01697644
• Lead Sponsor: Novo Nordisk A/S

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 1990-10
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-02
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Completion of the GHRETARD/BPD/20/NL trial
• Written informed consent from child and/or parents/guardians before continuation in the extension trial

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose	somatropin	-
High dose	somatropin	-

Primary Outcome Measures

Name	Time	Method
Linear growth (height during childhood)
Final height
Bone maturation
Pubertal development

Secondary Outcome Measures

Name	Time	Method
Adverse events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇳🇱 Rotterdam, Netherlands