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An Observational Study on Treatment Compliance by Children Treated With Growth Hormone (IMPACT)

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: February 12, 2010
Last updated: June 25, 2014
Last verified: June 2014
This study is conducted in Europe. This observational study aims at evaluating compliance with growth hormone treatment in children and identifying factors influencing compliance.

Condition Intervention
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Behavioral: No treatment given

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: IMprove PAtient Compliance sTudy: An Observational, Cross-sectional Study on Children Treated With Growth Hormone in France

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Average number of injections omitted during the previous month [ Time Frame: measured over the past 2 months (retrospective data collection) ]

Enrollment: 0
Study Start Date: February 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Behavioral: No treatment given
No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children treated for at least one year with growth hormone with any growth hormone product whatever the reason for prescription

Inclusion Criteria:

  • Child treated for at least one year with growth hormone any growth hormone product
  • Followed by the participating paediatrician for at least 1 year.

Exclusion Criteria:

  • Refusal to participate
  • Child and/or parent unable to give consent or fill out the questionnaires
  • Child participating in a therapeutic trial
  Contacts and Locations
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Please refer to this study by its identifier: NCT01068639

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: NCT01068639     History of Changes
Other Study ID Numbers: GH-3787
U1111-1113-2490 ( Other Identifier: WHO )
Study First Received: February 12, 2010
Last Updated: June 25, 2014

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on April 28, 2017