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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PenMate device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NordiFlex PenMate™ | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects from secondary care physicians who prescribe growth hormone will be included in the study. Children who are available for Norditropin® treatment in accordance with the labelling will be included in the study: Newly-diagnosed subjects who have never received growth hormone therapy before and subjects in whom physician identifies a need for switch to another growth hormone preparation
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Mainz | 55127 | Germany | |||
| Novo Nordisk Investigational Site |
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| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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| 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 |
| Alphen aan den Rijn |
| Netherlands |
| Novo Nordisk Investigational Site | Malmö | 202 15 | Sweden |
| Novo Nordisk Investigational Site | Malmö | SE-202 15 | Sweden |