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

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

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.

Study Overview

• Status: Completed
• Conditions: Foetal Growth Problem; Small for Gestational Age
• Intervention / Treatment: Drug: somatropin

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Baracaldo, Spain, 48903
    • Novo Nordisk Investigational Site
  • Barcelona, Spain, 08035
    • Novo Nordisk Investigational Site
  • Cádiz, Spain, 11009
    • Novo Nordisk Investigational Site
  • Córdoba, Spain, 14004
    • Novo Nordisk Investigational Site
  • El Palmar, Spain, 30120
    • Novo Nordisk Investigational Site
  • Esplugues Llobregat, Spain, 08950
    • Novo Nordisk Investigational Site
  • Granada, Spain, 18012
    • Novo Nordisk Investigational Site
  • Madrid, Spain, 28009
    • Novo Nordisk Investigational Site
  • Madrid, Spain, 28046
    • Novo Nordisk Investigational Site
  • Málaga, Spain, 29011
    • Novo Nordisk Investigational Site
  • Santa Cruz de Tenerife, Spain, 38010
    • Novo Nordisk Investigational Site
  • Santiago de Compostela, Spain, 15705
    • Novo Nordisk Investigational Site
  • Sevilla, Spain, 41013
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Argente J, Gracia R, Ibanez L, Oliver A, Borrajo E, Vela A, Lopez-Siguero JP, Moreno ML, Rodriguez-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 and without spontaneous catch-up growth: results of a multicenter, controlled, randomized, open clinical trial. J Clin Endocrinol Metab. 2007 Aug;92(8):3095-101. doi: 10.1210/jc.2007-0078. Epub 2007 May 29.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Actual): June 1, 2005
• Study Completion (Actual): June 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 17, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: GHRETARD-1106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No