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Completed

NCT Number: NCT00519844

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

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.

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Key information

Conditions

Foetal Growth Problem Small for Gestational Age

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lyon, 69000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somatropin

Drug

Primary outcomes

  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 outcomes

  1. Clinical (adverse events)

  2. Biological (fasting glucose, fasting insulin, liver enzymes)

  3. Tolerance of the treatment

  4. Compliance

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Assessment of Satisfaction With Growth Hormone Treatment in Children Born Small for Gestational Age: Benefits of Galenic Form of the Product

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 23, 2007
Registry last updated
Nov 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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