Chronic Kidney Disease, Chronic Renal Insufficiency, Delivery Systems, Foetal Growth Problem, Genetic Disorder, Growth Hormone Deficiency in Children, Growth Hormone Disorder, Small for Gestational Age, Turner Syndrome
Conditions
Brief 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.
Interventions
DEVICENorditropin NordiFlex®
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
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used | Week 6 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Week 0 | 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). |
| Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Week 0 | 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). |
| Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | Week 0 | 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. |
| Ease of Learning Assessed by the Physician or the Nurse: Ease of Training | Week 6 | 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). |
| Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Week 0 | 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). |
| Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Week 6 | 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. |
| Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | Week 0 | 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. |
| Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment | Week 6 | 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. |
| Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | Weeks 0 - 6 | — |
| Ease of Learning Assessed by the Physician or the Nurse: Time Learning | Week 6 | 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. |
Countries
France
Participant flow
Recruitment details
The trial was conducted in France (38 sites). Recruitment period occurred from 17-Nov-2010 to 18-Apr-2011.
Pre-assignment details
Eligible participants had to receive training for the use of Nordiflex® system. A member of the investigator's team, physician or nurse, was in charge of this training. At inclusion and before receiving treatment, participants or parents had to complete a questionnaire about the ease of use of the previously used device.
Participants by arm
| Arm | Count |
|---|---|
| Norditropin NordiFlex® 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). | 103 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Norditropin NordiFlex® |
|---|---|
| Age, Continuous | 11.7 years STANDARD_DEVIATION 2.94 |
| Body Mass Index (BMI) | 18.1 kg/m^2 STANDARD_DEVIATION 4.26 |
| Duration of growth hormone treatment | 4.18 years STANDARD_DEVIATION 2.81 |
| Gender Female | 43 Participants |
| Gender Male | 60 Participants |
| Height | 141.0 cm STANDARD_DEVIATION 16.5 |
| Region of Enrollment France | 103 participants |
| Weight | 37.3 kg STANDARD_DEVIATION 16 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 103 |
| serious Total, serious adverse events | 0 / 103 |
Outcome results
Primary
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.
Time frame: Week 6
Population: Per protocol set (PP): All subjects in the ITT set using NordiFlex® and had completed the trial without any significant violation of the inclusion/exclusion criteria or any other aspect of the protocol considered to potentially affect the efficacy results.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin NordiFlex® | The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used | 6.98 units on a scale | Standard Deviation 2.46 |
Primary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Norditropin NordiFlex® | The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used | 6.89 units on a scale | Standard Deviation 2.52 |
Secondary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Overall simplicity | 82.5 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Dose selection | 35.0 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Maximum available dose | 15.5 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Dose adjustment | 64.1 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Easiness of injection | 26.2 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | Improvement of compliance or motivation | 27.2 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products | No added values | 4.85 percentage of participants |
Secondary
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).
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Ease of Training | Very easy | 72.8 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Ease of Training | Easy | 26.2 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Ease of Training | Difficult | 0.97 percentage of participants |
Secondary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Time Learning | 6-10 minutes | 40.0 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Time Learning | 11-15 minutes | 26.0 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Time Learning | 16-30 minutes | 30.0 percentage of participants |
| Norditropin NordiFlex® | Ease of Learning Assessed by the Physician or the Nurse: Time Learning | 31 minutes - 1 hour | 4.0 percentage of participants |
Secondary
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Time frame: Weeks 0 - 6
Population: The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment. The adverse events and technical complaints were collected during the treatment period (6 weeks after inclusion).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | Serious adverse events | 0 participants |
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | Medical event of special interest (MESI) | 0 participants |
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | At least one technical complaint | 14 participants |
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | NordiFlex® pen technical complaint | 8 participants |
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | PenMate technical complaint | 10 participants |
| Norditropin NordiFlex® | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | Other adverse events greater than or equal to 5% | 0 participants |
Secondary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | Yes | 41.2 percentage of participants |
| Norditropin NordiFlex® | Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | No | 58.8 percentage of participants |
Secondary
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.
Time frame: Week 0
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | Yes | 28.2 percentage of participants |
| Norditropin NordiFlex® | Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection | No | 71.8 percentage of participants |
Secondary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For two patients, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment | Nordiflex® | 64.36 percentage of participants |
| Norditropin NordiFlex® | Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment | Previous system | 34.65 percentage of participants |
| Norditropin NordiFlex® | Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment | None of them | 0.99 percentage of participants |
Secondary
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).
Time frame: Week 0
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For seven patients, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Very easy | 26.0 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Easy | 40.6 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Fairly easy | 19.8 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Difficult | 11.5 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Very difficult | 2.08 percentage of participants |
Secondary
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).
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Very easy | 84.0 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Easy | 13.0 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Fairly easy | 2.0 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Difficult | 1.0 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Modification | Very difficult | 0.00 percentage of participants |
Secondary
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).
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.~For one patient, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Very easy | 66.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Easy | 21.6 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Fairly easy | 8.82 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Difficult | 2.94 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Very difficult | 0 percentage of participants |
Secondary
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).
Time frame: Week 0
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Very easy | 55.3 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Easy | 38.8 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Fairly easy | 4.85 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Difficult | 0.97 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness | Very difficult | 0 percentage of participants |
Secondary
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).
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Very easy | 62.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Easy | 22.5 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Fairly easy | 12.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Difficult | 0.98 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Very difficult | 0.98 percentage of participants |
Secondary
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).
Time frame: Week 0
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For three patients, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Very easy | 44.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Easy | 43.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Fairly easy | 9.71 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Difficult | 1.94 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Injection Easiness | Very difficult | 0 percentage of participants |
Secondary
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.
Time frame: Week 0
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | Below 5 minutes | 86.4 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | 5-10 minutes | 11.7 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | 10-20 minutes | 1.94 percentage of participants |
Secondary
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.
Time frame: Week 6
Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. For one patient, no data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | Below 5 minutes | 93.1 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | 5-10 minutes | 5.88 percentage of participants |
| Norditropin NordiFlex® | Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection | 10-20 minutes | 0.98 percentage of participants |