Phase 4
N=103
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Growth Hormone Disorder · Growth Hormone Deficiency in Children · Foetal Growth Problem · Small for Gestational Age · Genetic Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01245374 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used — 6.89 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Norditropin NordiFlex® (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used |
6.98 | — |
| PRIMARY The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used |
6.98 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness |
66.7; 21.6; 8.82; 2.94; 0 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Dose Modification |
84.0; 13.0; 2.0; 1.0; 0.00 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Injection Easiness |
62.7; 22.5; 12.7; 0.98; 0.98 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection |
93.1; 5.88; 0.98 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness |
66.7; 21.6; 8.82; 2.94; 0 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Dose Modification |
84.0; 13.0; 2.0; 1.0; 0.00 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Injection Easiness |
62.7; 22.5; 12.7; 0.98; 0.98 | — |
| SECONDARY Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection |
93.1; 5.88; 0.98 | — |
| SECONDARY Ease of Learning Assessed by the Physician or the Nurse: Ease of Training |
72.8; 26.2; 0.97 | — |
| SECONDARY Ease of Learning Assessed by the Physician or the Nurse: Time Learning |
40.0; 26.0; 30.0; 4.0 | — |
| SECONDARY Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products |
82.5; 35.0; 15.5; 64.1; 26.2; 27.2 | — |
| SECONDARY Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection |
41.2; 58.8 | — |
| SECONDARY Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection |
41.2; 58.8 | — |
| SECONDARY Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment |
64.36; 34.65; 0.99 | — |
| SECONDARY Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial |
0; 0; 14; 8; 10; 0 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01245374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.