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Growth Hormone Treatment in Children Born Small for Gestational Age: Assessment of Satisfaction

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: August 22, 2007
Last updated: November 11, 2015
Last verified: November 2015
This trial is conducted in Europe. The aim of this trial is to assess satisfaction with growth hormone treatment in children of both sexes born small for gestational age and who are receiving growth hormone treatment.

Condition Intervention Phase
Foetal Growth Problem Small for Gestational Age Drug: somatropin Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference [ Time Frame: after 3 months of treatment ]

Secondary Outcome Measures:
  • Clinical (adverse events)
  • Biological (fasting glucose, fasting insulin, liver enzymes)
  • Tolerance of the treatment
  • Compliance

Enrollment: 5
Study Start Date: July 2005
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children treated for 3 years with Maxomat® because of small for gestational age
  • Postnatal growth failure by the age of 3 years or more
  • No associated growth hormone deficiency
  • Height growth velocity greater than 2 cm/yr over the 12 month period preceding the inclusion
  • Bone age no more than 13 years for girls and no more than 15 years for boys

Exclusion Criteria:

  • Known, evolving tumour
  • Hypertrophic cardiomyopathy
  • Hypertension not controlled on maximum therapy
  • Benign intracranial hypertension
  • Known glucose intolerance or known diabetes mellitus
  • Acute or active chronic hepatitis
  • Chronic renal failure
  • Chromosomal and/or genetic syndromes (other than Silver-Russell syndrome) or abnormality
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Please refer to this study by its identifier: NCT00519844

Lyon, France, 69000
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00519844     History of Changes
Other Study ID Numbers: GHLIQUID-1670
2005-000318-11 ( EudraCT Number )
Study First Received: August 22, 2007
Last Updated: November 11, 2015

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on June 22, 2017