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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01068639
First received: February 12, 2010
Last updated: June 25, 2014
Last verified: June 2014
  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:


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) ] [ 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: 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 25, 2014
Health Authority: Unspecified

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on October 23, 2014