Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

Novo Nordisk

Status: Completed

Conditions: Growth Hormone Deficiency in Children; Growth Hormone Disorder; Delivery Systems

Treatments: Device: NordiFlex PenMate™

Study type: Observational

Funder types: Industry

Identifiers

NCT01500486

GH-3717

Details and patient eligibility

About

This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.

Enrollment: 84 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the physician decision has been made to use Norditropin Nordiflex® growth hormone therapy in accordance with the locally approved labelling, any subject is eligible for the study, including newly diagnosed subjects who have never received growth hormone therapy before and subjects who were treated with the other growth hormone products (with exclusion of patients who received previously Norditropin Nordiflex®) and need to be switched to a new product. The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

• Contraindications to Norditropin® growth hormone therapy
• Subjects who have received Norditropin NordiFlex® prior to this study

Trial design

84 participants in 1 patient group

PenMate device

Treatment:

Device: NordiFlex PenMate™