Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00557336

Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Condition	Intervention	Phase
Small for Gestational Age (SGA)	Drug: somatropin	Phase III

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Height gain according to birth group, age of onset, the treatment and Tanner stage [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Height SDS for bone age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
Height velocity SDS for bone age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]
Height velocity for chronological age [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	4 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria:

Diabetes
Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
Previous or ongoing growth hormone therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557336

Locations

Spain

Madrid, Spain, 28041

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Llanos Moreno, PhD

Novo Nordisk Pharma SA

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	GHLIQUID-1523
Study First Received:	November 12, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00557336
Health Authority:	Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on January 15, 2009