Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Phase 4

Completed

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

• Registration Number: NCT01734447
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-30
• Primary Completion: 2003-04-30
• Study Completion: 2003-04-30
• Study First Submitted: 2012-11-22
• Study First Submitted QC: 2012-11-22
• Study First Posted: 2012-11-27
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Patients born with IUGR enrolled in trial GHRETARD/F/1/F
• Bone age below 14 years in boys and 12 years in girls

Exclusion Criteria

• Bone age above 14 years in boys and 12 years in girls

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1.2, continuous treatment	somatropin	-
1.2, non-continuous treatment	somatropin	-
2.4, non-continuous treatment	somatropin	-

Primary Outcome Measures

Name	Time	Method
Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion

Secondary Outcome Measures

Name	Time	Method
Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Pubertal development, assessed according to Tanner method
Height velocity
Final height
Number of Adverse Events

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇫🇷 Paris, France