Trial Outcomes & Findings for Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents (NCT NCT01245374)
NCT ID: NCT01245374
Last Updated: 2017-02-27
Results Overview
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.
COMPLETED
PHASE4
103 participants
Week 6
2017-02-27
Participant Flow
The trial was conducted in France (38 sites). Recruitment period occurred from 17-Nov-2010 to 18-Apr-2011.
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.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
103
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Baseline characteristics by cohort
| Measure |
Norditropin NordiFlex®
n=103 Participants
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).
|
|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 2.94 • n=5 Participants
|
|
Gender
Female
|
43 Participants
n=5 Participants
|
|
Gender
Male
|
60 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
103 participants
n=5 Participants
|
|
Height
|
141.0 cm
STANDARD_DEVIATION 16.5 • n=5 Participants
|
|
Weight
|
37.3 kg
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Body Mass Index (BMI)
|
18.1 kg/m^2
STANDARD_DEVIATION 4.26 • n=5 Participants
|
|
Duration of growth hormone treatment
|
4.18 years
STANDARD_DEVIATION 2.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 6Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
|
6.89 units on a scale
Standard Deviation 2.52
|
PRIMARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=98 Participants
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)
|
|---|---|
|
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
|
6.98 units on a scale
Standard Deviation 2.46
|
SECONDARY outcome
Timeframe: Week 0Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Very easy
|
55.3 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Easy
|
38.8 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Fairly easy
|
4.85 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Difficult
|
0.97 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Very difficult
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0Population: 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.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=96 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Very easy
|
26.0 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Easy
|
40.6 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Fairly easy
|
19.8 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Difficult
|
11.5 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Very difficult
|
2.08 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0Population: 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.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=100 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Very easy
|
44.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Easy
|
43.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Fairly easy
|
9.71 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Difficult
|
1.94 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Very difficult
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Below 5 minutes
|
86.4 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
5-10 minutes
|
11.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
10-20 minutes
|
1.94 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=102 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Very easy
|
66.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Easy
|
21.6 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Fairly easy
|
8.82 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Difficult
|
2.94 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Very difficult
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=100 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Very easy
|
84.0 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Easy
|
13.0 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Fairly easy
|
2.0 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Difficult
|
1.0 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Very difficult
|
0.00 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=102 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Very easy
|
62.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Easy
|
22.5 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Fairly easy
|
12.7 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Difficult
|
0.98 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Very difficult
|
0.98 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=102 Participants
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)
|
|---|---|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Below 5 minutes
|
93.1 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
5-10 minutes
|
5.88 percentage of participants
|
|
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
10-20 minutes
|
0.98 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Very easy
|
72.8 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Easy
|
26.2 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Difficult
|
0.97 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=100 Participants
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)
|
|---|---|
|
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
6-10 minutes
|
40.0 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
11-15 minutes
|
26.0 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
16-30 minutes
|
30.0 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
31 minutes - 1 hour
|
4.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Overall simplicity
|
82.5 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Dose selection
|
35.0 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Maximum available dose
|
15.5 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Dose adjustment
|
64.1 percentage of participants
|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Easiness of injection
|
26.2 percentage of participants
|
|
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
|
|
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
No added values
|
4.85 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Yes
|
28.2 percentage of participants
|
|
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
No
|
71.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Yes
|
41.2 percentage of participants
|
|
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
No
|
58.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 6Population: 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.
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.
Outcome measures
| Measure |
Norditropin NordiFlex®
n=101 Participants
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)
|
|---|---|
|
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
Nordiflex®
|
64.36 percentage of participants
|
|
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
Previous system
|
34.65 percentage of participants
|
|
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
None of them
|
0.99 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0 - 6Population: 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).
Outcome measures
| Measure |
Norditropin NordiFlex®
n=103 Participants
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)
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
Adverse Events
Norditropin NordiFlex®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Novo Nordisk reserves the right to not release data until specified milestones, including the right to not release interim results of clinical trials. At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER