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

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents

Conditions
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Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age, Genetic Disorder, Turner Syndrome, Chronic Kidney Disease, Chronic Renal Insufficiency, Delivery Systems

Intervention / Treatment
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* Device: Norditropin NordiFlex®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nordiflex Norditropin®<br>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) | Device: Norditropin NordiFlex®<br>* Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used | Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state. | Week 6 | 
| The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used | Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state. | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 0 | 
| Percentage of Participants Evaluating Simplicity of Use: Dose Modification | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 0 | 
| Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 0 | 
| Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes. | Week 0 | 
| Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 6 | 
| Percentage of Participants Evaluating Simplicity of Use: Dose Modification | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 6 | 
| Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult). | Week 6 | 
| Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes. | Week 6 | 
| Ease of Learning Assessed by the Physician or the Nurse: Ease of Training | The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult). | Week 6 | 
| Ease of Learning Assessed by the Physician or the Nurse: Time Learning | The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour. | Week 6 | 
| Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables. | Week 6 | 
| Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection. | Week 0 | 
| Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection. | Week 6 | 
| Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment | The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy. | Week 6 | 
| Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial |  | Weeks 0 - 6 |