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

Novo Nordisk A/S77 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Interventions

Norditropin NordiFlex®DRUG

Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

Eligibility

Sex: ALLMax age: 16 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Usability of growth hormone injection device assessed by a quantitative scale

Time frame: after 3 months of growth hormone treatment

Secondary Outcomes

Number of adverse events

Time frame: from 0 - 3 months of growth hormone treatment

Number of technical complaints

Time frame: from 0 to 3 months of growth hormone treatment

Data from ClinicalTrials.gov

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