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Completed

NCT Number: NCT00184691

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

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.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Barakaldo, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Effect on Efficacy: Height SDS for chronological age

    Time frame: after 48 months

  2. Safety: Bone maturation and glucose metabolism

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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