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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00519844
First received: August 22, 2007
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical (adverse events) [ Designated as safety issue: No ]
  • Biological (fasting glucose, fasting insulin, liver enzymes) [ Designated as safety issue: No ]
  • Tolerance of the treatment [ Designated as safety issue: No ]
  • Compliance [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519844

Locations
France
Lyon, France, 69000
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Anders Dejgaard, MD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00519844     History of Changes
Other Study ID Numbers: GHLIQUID-1670, 2005-000318-11
Study First Received: August 22, 2007
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on May 16, 2013