| 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. | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Mean | Standard Deviation | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | 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. | Posted | | Number | | percentage of participants | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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). | 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. | Posted | | Number | | percentage of participants | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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. | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| 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). | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 0 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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). |
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| 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. | 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. | Posted | | Number | | percentage of participants | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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| Secondary | Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial | | 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). | Posted | | Number | | participants | | Weeks 0 - 6 | | | | ID | Title | Description |
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| OG000 | 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) |
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