Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton�
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Hormone Deficiency
Intervention: Somatropin (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
Summary
The purpose of this study is to investigate the long-term treatment with Zomacton® for
pituitary short stature in children with insufficient growth hormone production and/or short
stature caused by Turner's syndrome.
Clinical Details
Official title: Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Efficacy of Zomacton® treatment measured by the increase in body height per annuum
Secondary outcome: Efficacy of Zomacton® treatment measured by the increase in body weight per annuumSafety of Zomacton® and the application device measured by local adverse reactions to the application device
Eligibility
Minimum age: 3 Years.
Maximum age: 18 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- therapeutic need according to the approved specific products characteristics (SPC)
Exclusion Criteria:
- contraindication according to the SPC
Locations and Contacts
Additional Information
Starting date: January 2013
Last updated: January 31, 2013
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