Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Genetic Disorder; Turner Syndrome
• Interventions: Drug: somatropin

• Registration Number: NCT01604161
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-23
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-02
• Last Update Posted: 2015-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2016

Inclusion Criteria

• Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed

Exclusion Criteria

• Diabetic
• Patients with malignant tumors
• Women who are either pregnant or likely to be pregnant
• Known or suspected allergy to study product(s) or related products

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatropin	somatropin	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in height	Week 0, Month 36, final height is reached
Incidence of adverse reactions (ADRs)	36 months, accumulation of study period