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

Small for Gestational Age Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519844
• Other study ID #: GHLIQUID-1670
• Secondary ID: 2005-000318-11
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2007
• Last updated: November 11, 2015
• Start date: July 2005
• Est. completion date: January 2006

Study information

• Verified date: November 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: January 2006
• Est. primary completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction/preference with the method of treatment assesses by means of a satisfaction questionnaire and a standard questionnaire of preference		after 3 months of treatment	No
Secondary	Clinical (adverse events)			No
Secondary	Biological (fasting glucose, fasting insulin, liver enzymes)			No
Secondary	Tolerance of the treatment			No
Secondary	Compliance			No

External Links

•   Clinical Trials at Novo Nordisk