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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

September 13, 2005
July 10, 2012
April 1999
June 2005   (final data collection date for primary outcome measure)
  • 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 ]
  • Effect after 48 months on:
  • - Bone maturation and glucose metabolism
  • Efficacy:
  • - Height SDS for chronological age
  • Safety:
Complete list of historical versions of study NCT00184691 on ClinicalTrials.gov Archive Site
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 ]
  • 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.
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Foetal Growth Problem
  • Small for Gestational Age
Drug: somatropin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
June 2005
June 2005   (final data collection date for primary outcome measure)

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
Both
2 Years to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00184691
GHRETARD-1106
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Llanos Moreno Novo Nordisk Pharma S.A
Novo Nordisk A/S
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP