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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Status: Withdrawn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 annuum

Safety 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

Page last updated: August 23, 2015

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