Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365351
First received: June 1, 2011
Last updated: April 23, 2014
Last verified: April 2014

June 1, 2011
April 23, 2014
November 2007
December 2016   (final data collection date for primary outcome measure)
Efficacy of ZOMACTON [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
measured by: body height, increase of body height per annum
Same as current
Complete list of historical versions of study NCT01365351 on ClinicalTrials.gov Archive Site
  • Efficacy measured by further parameters [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors
  • Safety of Zomacton and application device [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory
Same as current
Not Provided
Not Provided
 
Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON
Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Clinics and private practices

Growth Hormone Deficiency
Other: Growth hormone
Drug given by prescription
Growth hormone
Children with growth hormone deficiency
Intervention: Other: Growth hormone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
400
December 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01365351
ZOM/011207/03
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP