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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:
ClinicalTrials.gov Identifier:
NCT00184691
First Posted: September 16, 2005
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
September 13, 2005
September 16, 2005
January 18, 2017
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 ]
  • Safety: Bone maturation and glucose metabolism
  • Effect after 48 months on:
  • Efficacy:
  • - Height SDS for chronological age
  • Safety:
  • - Bone maturation and glucose metabolism
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
  • 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Foetal Growth Problem
  • Small for Gestational Age
Drug: somatropin
Not Provided
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 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. Epub 2007 May 29.

*   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
Sexes Eligible for Study: All
2 Years to 5 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00184691
GHRETARD-1106
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

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