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

Novo Nordisk

Status: Completed

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

Treatments: Drug: Norditropin NordiFlex®

Study type: Observational

Funder types: Industry

Identifiers

NCT01327924

GH-3870

U1111-1119-8619 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

77 participants in 1 patient group

Norditropin NordiFlex® users

Treatment:

Drug: Norditropin NordiFlex®