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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184691
First received: September 13, 2005
Last updated: July 10, 2012
Last verified: July 2012
  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:


Further study details as provided by Novo Nordisk A/S:

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 A/S
Investigators
Study Director: Llanos Moreno Novo Nordisk Pharma S.A
  More Information

Additional Information:
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 April 22, 2014