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Efficacy and Safety of Growth Hormone Treatment in Children Small for Gestational Age

This study has been completed.
Information provided by:
Novo Nordisk A/S Identifier:
First received: November 12, 2007
Last updated: June 28, 2012
Last verified: June 2012
This trial is conducted in Europe. The aim of this clinical trial is to evaluate the height gain during 12 months of growth hormone treatment in children born small for gestational age due to intrauterine growth retardation.

Condition Intervention Phase
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Efficacy and Safety of Somatropin in SGA Children Due to IUGR

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Height gain according to birth group, age of onset, the treatment and Tanner stage [ Time Frame: during 12 months of treatment ]

Secondary Outcome Measures:
  • Height SDS for bone age [ Time Frame: during 12 months of treatment ]
  • Height velocity SDS for bone age [ Time Frame: during 12 months of treatment ]
  • Height velocity for chronological age [ Time Frame: during 12 months of treatment ]

Enrollment: 160
Study Start Date: July 2003
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Born small for gestational age (SGA) due to intrauterine growth retardation (IUGR) defined as birth length and/or weight below P10
  • Chronological age at least 4 years old until bone age maturation of maximum 12 years for girls and maximum 13,5 for boys at time of inclusion in the study
  • Insufficient catch-up growth (height lesser than or equal to -2.5 SDS for chronological age
  • Normal response to GH stimulation test (greater than 10 ng/mL)

Exclusion Criteria:

  • Diabetes
  • Growth retardation associated with infections severe chronic diseases (including chromosomal anomaly or nutritional disorders)
  • Treatment with any medical product (anabolic drugs, sex steroids, etc.) which may interfere with GH effects
  • History or presence of severe disease that could interfere with GH treatment/participation in the trial, e.g. active malignancy
  • Previous or ongoing growth hormone therapy
  Contacts and Locations
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Please refer to this study by its identifier: NCT00557336

Madrid, Spain, 28041
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Llanos Moreno, PhD Novo Nordisk Pharma SA
  More Information

Additional Information:
Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S Identifier: NCT00557336     History of Changes
Other Study ID Numbers: GHLIQUID-1523 
Study First Received: November 12, 2007
Last Updated: June 28, 2012 processed this record on February 20, 2017