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

Small for Gestational Age Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00184691
• Other study ID #: GHRETARD-1106
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 17, 2017
• Start date: April 1999
• Est. completion date: June 2005

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin

Locations

Country	Name	City	State
Spain	Novo Nordisk Investigational Site	Baracaldo
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Cádiz
Spain	Novo Nordisk Investigational Site	Córdoba
Spain	Novo Nordisk Investigational Site	El Palmar
Spain	Novo Nordisk Investigational Site	Esplugues Llobregat
Spain	Novo Nordisk Investigational Site	Granada
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Madrid
Spain	Novo Nordisk Investigational Site	Málaga
Spain	Novo Nordisk Investigational Site	Santa Cruz de Tenerife
Spain	Novo Nordisk Investigational Site	Santiago de Compostela
Spain	Novo Nordisk Investigational Site	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Argente J, Gracia R, Ibáñez L, Oliver A, Borrajo E, Vela A, López-Siguero JP, Moreno ML, Rodríguez-Hierro F; Spanish SGA Working Group.. Improvement in growth after two years of growth hormone therapy in very young children born small for gestational age — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on Efficacy: Height SDS for chronological age		after 48 months
Primary	Safety: Bone maturation and glucose metabolism
Secondary	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

External Links

•   Clinical Trials at Novo Nordisk