Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

Novo Nordisk

Status and phase: Completed; Phase 4

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: Device: Norditropin NordiFlex®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245374

GH-3826

2009-017387-16 (EudraCT Number)

U1111-1117-1194 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.

Enrollment: 103 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children who can receive Norditropin® (somatropin) treatment according to the product labelling
• Treated with growth hormone for at least one year

Exclusion criteria

• Contraindications to Norditropin® growth hormone therapy
• Known or suspected hypersensitivity to somatropin or related products
• The receipt of any investigational medicinal product within 3 months prior to study start
• Life threatening disease, for example cancer
• Pregnancy or the intention of becoming pregnant

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

Nordiflex Norditropin®

Experimental group

Description:

Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)

Treatment:

Device: Norditropin NordiFlex®