Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

Completed

• Conditions: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Genetic Disorder; Turner Syndrome; Foetal Growth Problem; Chronic Renal Insufficiency; Delivery Systems; Small for Gestational Age; Chronic Kidney Disease
• Interventions: Drug: Norditropin NordiFlex®

• Registration Number: NCT01327924
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-03-31
• Study Start: 2011-04
• Study First Posted: 2011-04-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
• Subjects who receive Norditropin NordiFlex® according to the SPC

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Exclusion Criteria

• Known or suspected allergy to study product(s) or related products
• Child and/or parent unable to give consent or fill out the questionnaires
• The receipt of any investigational medicinal product within 3 months prior to this study
• Suffer from a life-threatening disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Norditropin NordiFlex® users	Norditropin NordiFlex®	-

Primary Outcome Measures

Name	Time	Method
Usability of growth hormone injection device assessed by a quantitative scale	after 3 months of growth hormone treatment

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	from 0 - 3 months of growth hormone treatment
Number of technical complaints	from 0 to 3 months of growth hormone treatment