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

Condition(s) targeted: Growth Hormone Disorder; Growth Hormone Deficiency in Children; Genetic Disorder; Turner Syndrome; Foetal Growth Problem; Small for Gestational Age; Chronic Kidney Disease; Chronic Renal Insufficiency; Delivery Systems

Intervention: Norditropin NordiFlex® (Drug)

Phase: N/A

Status: Completed

Sponsored by: Novo Nordisk A/S

Official(s) and/or principal investigator(s):
Global Clinical Registry (GCR, 1452), Study Director, Affiliation: Novo Nordisk A/S

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.

Official title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Usability of growth hormone injection device assessed by a quantitative scale

Secondary outcome:

Number of adverse events

Number of technical complaints

Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.

Criteria:

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

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

Paris La défense cedex 92932, France

Clinical Trials at Novo Nordisk

Starting date: April 2011
Last updated: June 23, 2014