Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

Growth Hormone Deficiency Clinical Trial

Official title:

Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01731028
• Other study ID #: 000091
• Status: Withdrawn
• Phase: N/A
• First received: November 16, 2012
• Last updated: January 31, 2013
• Start date: January 2013
• Est. completion date: June 2018

Study information

• Verified date: January 2013
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• therapeutic need according to the approved specific products characteristics (SPC)

Exclusion Criteria:

• contraindication according to the SPC

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• Somatropin
Somatropin powder and solvent for solution for injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Zomacton® treatment measured by the increase in body height per annuum		5 years	No
Secondary	Efficacy of Zomacton® treatment measured by the increase in body weight per annuum		5 years	No
Secondary	Safety of Zomacton® and the application device measured by local adverse reactions to the application device		5 years	Yes