Delivery Systems, Growth Hormone Deficiency in Children, Growth Hormone Disorder
Conditions
Brief summary
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.
Interventions
DEVICENordiFlex PenMate™
Subjects whom will be offered growth hormone (Norditropin NordiFlex®) on prescription as part of normal clinical practice will be asked to evaluate the NordiFlex PenMate™ device.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects that find growth hormone injection using Norditropin Nordiflex® with NordiFlex PenMate™ very easy or easy as assessed by patient/parent questionnaire | Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires | Week 0 |
| Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire | Week 12 |
| Compliance to treatment as assessed by patient/parent diary | Week 12 |
| Evaluation of tolerability, when using Norditropin Nordiflex® with NordiFlex PenMate™, by collecting Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) and clinical technical complaints | Week 12 |
Countries
Germany, Netherlands, Sweden
Outcome results
None listed