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

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.

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Key information

Conditions

Growth Hormone Disorder Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Chronic Disease Chronic Kidney Disease Chronic Renal Insufficiency Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Delivery Systems Disease Attributes Disorders of Sex Development Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Foetal Growth Problem Genetic Diseases, Inborn Genetic Disorder Gonadal Disorders Gonadal Dysgenesis Growth Hormone Deficiency in Children Heart Defects, Congenital Heart Diseases Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Sex Chromosome Disorders Sex Chromosome Disorders of Sex Development Small for Gestational Age Turner Syndrome Urogenital Abnormalities Urogenital Diseases Urologic Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Paris La Défense Cedex, 92932, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Apr 4, 2011
Registry last updated: Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed