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

Withdrawn

• Conditions: Growth Hormone Deficiency
• Interventions: Drug: Somatropin

• Registration Number: NCT01731028
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Status Verified: 2013-01
• Study Start: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• contraindication according to the SPC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatropin	Somatropin	Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization

Primary Outcome Measures

Name	Time	Method
Efficacy of Zomacton® treatment measured by the increase in body height per annuum	5 years

Secondary Outcome Measures

Name	Time	Method
Efficacy of Zomacton® treatment measured by the increase in body weight per annuum	5 years
Safety of Zomacton® and the application device measured by local adverse reactions to the application device	5 years