Growth Hormone Treatment of Children Born With Retarded Intrauterine Growth at Age 2-5 Years - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184691

Purpose

This trial is conducted in Europe. Objectives: The aim of this study is to evaluate the efficacy and tolerance of a new growth hormone (GH) formulation, in the treatment of children born with retarded intrauterine growth, starting at age 2 to 5 years.

Trial Design: The study will be multicenter, open label, parallel, randomized, Phase IIIb, controlled.

Condition	Intervention	Phase
Fetal Growth Retardation	Drug: somatropin	Phase III

Drug Information available for: Somatotropin Somatropin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone Which Will be Started Randomly at the Ages of 2 to 5, in Children Diagnosed of IUGR

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Effect on Efficacy: Height SDS for chronological age [ Time Frame: after 48 months ]
Safety: Bone maturation and glucose metabolism

Secondary Outcome Measures:

Efficacy: Height SDS for bone age; Height velocity SDS for bone age; Height velocity SDS for chronological age; Serum IGF-I and IGFBP-3 levels

Estimated Enrollment:	72
Study Start Date:	April 1999

Eligibility

Ages Eligible for Study:	2 Years to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

IUGR defined as birth length and/or weight below the lower limit (< P10) of the Lubchenco curves for the gestational age.
Chronological age = 2-5 years.
HV below average for CA.
Insufficient catch-up growth (Height < P3 for chronological age, according to Hernández).
Parental height greater than or equal to -2 SDS of average, that is, 160 cm or more for the father and 148 cm or more for the mother.
Normal response to GH stimulation test (greater tan or equal to 10 ng/mL).
Bone age (measured through Greulich and Pyle method) less than or equal to CA.

Exclusion Criteria:

Children born from multiple pregnancy.
Children with post-ischemic encephalopathy.
Recorded malformative syndromes associated to short stature (Silver-Russell, Rubinstein Taybi, Seckel etc.).
Any metabolic or endocrinological disorder (diabetes mellitus, diabetes insipidus, congenital metabolic disorders, with the exception of thyroid diseases corrected by replacement therapy).
Any type of growth retardation associated to infections, embryopathies or severe chronic diseases (hemopathies, hepatopathies, malabsorptive pathology, neurologic alterations....).
Nutritional disorders (celiac disease) or osteodystrophies.
Patients who receive or received any treatment (anabolic drugs, sex steroids, etc.) likely to interfere with GH effects.
Abnormal karyotype.
Neoplasms.
Previous or ongoing chemotherapy and/or irradiation.
Renal dysfunction, defined as serum creatinine > 1 mg/dL.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184691

Locations

Spain

Madrid, Spain

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Llanos Moreno

Novo Nordisk Pharma S.A

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:	GHRETARD-1106
Study First Received:	September 13, 2005
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00184691
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Fetal Diseases
Pregnancy Complications
Growth Disorders
Fetal Growth Retardation

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 14, 2009