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

Purpose

This trial is conducted in Europe. The aim of this trial 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
Foetal Growth Problem Small for Gestational Age	Drug: somatropin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Effect on Efficacy: Height SDS for chronological age [ Time Frame: after 48 months ] [ Designated as safety issue: No ]
Safety: Bone maturation and glucose metabolism [ Designated as safety issue: No ]

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 [ Designated as safety issue: No ]

Enrollment:	78
Study Start Date:	April 1999
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

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

Additional Information:

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

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00184691 History of Changes
Other Study ID Numbers:	GHRETARD-1106
Study First Received:	September 13, 2005
Last Updated:	July 10, 2012
Health Authority:	Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on May 16, 2013