Efficacy on Height in SGA Children Treated With Growth Hormone

This study has been completed.

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184756

Purpose

This trial is conducted in Europe and Middle East. Growth hormone in SGA Children This trial compares a treated group of patients with an untreated group of patients.

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, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Two Years Treatment With Growth Hormone on Height in SGA Children.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Evaluate effect on Height in SGA Children Treated with Growth Hormone [ Time Frame: After 2 years of treatment ]

Secondary Outcome Measures:

Appetite
Height SDS, yearly

Estimated Enrollment:	180
Study Start Date:	November 2002

Eligibility

Ages Eligible for Study:	5 Years to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Born small for gestational age with length and/or weight at -2 SDS or below at time of birth, according to country specific references.
Severe growth failure with no catch up and with height at -2.5 SDS or below, according to country specific references, for chronological age at time of inclusion

Exclusion Criteria:

Growth Hormone Deficiency (GHD)
Treatment with any medical product which may interfere with GH effects
Growth retardation associated with infections, severe chronic diseases including chromosomal anomaly or nutritional disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184756

Locations

Czech Republic

Prague, Czech Republic
Finland

Fin-HUS, Finland
Germany

Leipzig, Germany
Israel

Be'er Sheva, Israel
Poland

Warszawa, Poland
Portugal

Porto, Portugal
Spain

Madrid, Spain
Sweden

Stockholm, Sweden

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Kirsten Jøns

Novo Nordisk

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-1424
Study First Received:	September 13, 2005
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00184756
Health Authority:	Poland: The Office for Registration of Medicinal Products, Medical Devices; and Biocides, Central Evidence of Clinical Trials

ClinicalTrials.gov processed this record on January 14, 2009