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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This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01068639
First received: February 12, 2010
Last updated: June 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Average number of injections omitted during the previous month [ Time Frame: measured over the past 2 months (retrospective data collection) ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01068639

Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Delphine Jaquet, MD phD 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: NCT01068639     History of Changes
Other Study ID Numbers: GH-3787, U1111-1113-2490
Study First Received: February 12, 2010
Last Updated: June 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
 Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013