Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01734447

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Foetal Growth Problem Small for Gestational Age	Drug: somatropin Drug: somatropin Drug: somatropin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

57 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 30, 2000

Actual Primary Completion Date :

Apr 30, 2003

Actual Study Completion Date :

Apr 30, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1.2, continuous treatment	Drug: somatropin 1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
Experimental: 1.2, non-continuous treatment	Drug: 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)
Experimental: 2.4, non-continuous treatment	Drug: 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)

Arm

Intervention/Treatment

Experimental: 1.2, continuous treatment

Drug: somatropin

1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months

Experimental: 1.2, non-continuous treatment

Drug: 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)

Experimental: 2.4, non-continuous treatment

Drug: 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)

Outcome Measures

Primary Outcome Measures

Glucose tolerance as assessed by hyperglycaemia induced by oral ingestion []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Paris		France

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Clinical Trials at Novo Nordisk

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01734447

Other Study ID Numbers:

GHRETARD/F/2/F

First Posted:

Nov 27, 2012

Last Update Posted:

Feb 28, 2017

Last Verified:

Feb 1, 2017

Additional relevant MeSH terms:

Fetal Growth Retardation

Study Results

No Results Posted as of Feb 28, 2017