We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01365351
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : June 2, 2017
Information provided by (Responsible Party):

June 1, 2011
June 3, 2011
June 2, 2017
December 1, 2007
June 2016   (Final data collection date for primary outcome measure)
Efficacy of ZOMACTON [ Time Frame: Up to 5 years ]
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 ]
    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 ]
    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 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.
June 2016
June 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
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
June 2017