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

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. Identifier: NCT00519844
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : November 13, 2015
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Foetal Growth Problem Small for Gestational Age Drug: somatropin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2005
Actual Primary Completion Date : January 2006
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Primary Outcome Measures :
  1. 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 :
  1. Clinical (adverse events)
  2. Biological (fasting glucose, fasting insulin, liver enzymes)
  3. Tolerance of the treatment
  4. Compliance

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00519844

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

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00519844     History of Changes
Other Study ID Numbers: GHLIQUID-1670
2005-000318-11 ( EudraCT Number )
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs