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

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ClinicalTrials.gov Identifier: NCT01245374
Recruitment Status : Completed
First Posted : November 22, 2010
Results First Posted : June 25, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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 Device: Norditropin NordiFlex®
Enrollment 103
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.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 103
Completed 99
Not Completed 4
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             3
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description 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 Number of Baseline Participants 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
11.7  (2.94)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 103 participants
Female
43
  41.7%
Male
60
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 103 participants
103
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 103 participants
141.0  (16.5)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 103 participants
37.3  (16.0)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 103 participants
18.1  (4.26)
Duration of growth hormone treatment  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 103 participants
4.18  (2.81)
1.Primary Outcome
Title The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.89  (2.52)
2.Primary Outcome
Title The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 98
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.98  (2.46)
3.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 55.3
Easy 38.8
Fairly easy 4.85
Difficult 0.97
Very difficult 0
4.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 96
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 26.0
Easy 40.6
Fairly easy 19.8
Difficult 11.5
Very difficult 2.08
5.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 44.7
Easy 43.7
Fairly easy 9.71
Difficult 1.94
Very difficult 0
6.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Below 5 minutes 86.4
5-10 minutes 11.7
10-20 minutes 1.94
7.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description

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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 66.7
Easy 21.6
Fairly easy 8.82
Difficult 2.94
Very difficult 0
8.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 84.0
Easy 13.0
Fairly easy 2.0
Difficult 1.0
Very difficult 0.00
9.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 62.7
Easy 22.5
Fairly easy 12.7
Difficult 0.98
Very difficult 0.98
10.Secondary Outcome
Title Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: percentage of participants
Below 5 minutes 93.1
5-10 minutes 5.88
10-20 minutes 0.98
11.Secondary Outcome
Title Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Very easy 72.8
Easy 26.2
Difficult 0.97
12.Secondary Outcome
Title Ease of Learning Assessed by the Physician or the Nurse: Time Learning
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of participants
6-10 minutes 40.0
11-15 minutes 26.0
16-30 minutes 30.0
31 minutes - 1 hour 4.0
13.Secondary Outcome
Title Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Overall simplicity 82.5
Dose selection 35.0
Maximum available dose 15.5
Dose adjustment 64.1
Easiness of injection 26.2
Improvement of compliance or motivation 27.2
No added values 4.85
14.Secondary Outcome
Title Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Yes 28.2
No 71.8
15.Secondary Outcome
Title Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) consists of all participants included in the trial and having signed the informed consent form.
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: percentage of participants
Yes 41.2
No 58.8
16.Secondary Outcome
Title Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: percentage of participants
Nordiflex® 64.36
Previous system 34.65
None of them 0.99
17.Secondary Outcome
Title Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Hide Description [Not Specified]
Time Frame Weeks 0 - 6
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Norditropin NordiFlex®
Hide Arm/Group Description:
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 Number of Participants Analyzed 103
Measure Type: Number
Unit of Measure: participants
Serious adverse events 0
Medical event of special interest (MESI) 0
At least one technical complaint 14
NordiFlex® pen technical complaint 8
PenMate technical complaint 10
Other adverse events greater than or equal to 5% 0
Time Frame The adverse events were collected during treatment period (6 weeks after inclusion).
Adverse Event Reporting Description The safety set consisted of all participants included in the trial and having taken at least one dose of trial treatment.
 
Arm/Group Title Norditropin NordiFlex®
Hide Arm/Group Description 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)
All-Cause Mortality
Norditropin NordiFlex®
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Norditropin NordiFlex®
Affected / at Risk (%)
Total   0/103 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Norditropin NordiFlex®
Affected / at Risk (%)
Total   0/103 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01245374     History of Changes
Other Study ID Numbers: GH-3826
U1111-1117-1194 ( Other Identifier: WHO )
2009-017387-16 ( EudraCT Number )
First Submitted: November 19, 2010
First Posted: November 22, 2010
Results First Submitted: April 18, 2012
Results First Posted: June 25, 2012
Last Update Posted: February 27, 2017