Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Small for Gestational Age Clinical Trial

Official title:

Discontinued Administration (6 Months a Year) of Growth Hormone to Children With Very Short Stature and Having Suffered From Intrauterine Growth Retardation: Safety and Effect on Growth of Long-term Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01734447
• Other study ID #: GHRETARD/F/2/F
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2012
• Last updated: February 27, 2017
• Start date: April 30, 2000
• Est. completion date: April 30, 2003

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: April 30, 2003
• Est. primary completion date: April 30, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
• somatropin
1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
• somatropin
2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion
Secondary	Bone Age determined according to Greulich and Pyle method and measured on the left hand X-ray
Secondary	Pubertal development, assessed according to Tanner method
Secondary	Height velocity
Secondary	Final height
Secondary	Number of Adverse Events

External Links

•   Clinical Trials at Novo Nordisk