Back to resultsNorditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Primary Purpose
Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Norditropin NordiFlex®
Sponsored by
About this trial
This is an interventional treatment trial for Growth Hormone Disorder
Eligibility Criteria
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
Sites / Locations
- Novo Nordisk Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nordiflex Norditropin®
Arm 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)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
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).
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).
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.
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).
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).
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).
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.
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).
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.
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.
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.
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.
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.
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01245374
Brief Title
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
Official Title
Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nordiflex Norditropin®
Arm Type
Experimental
Arm 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)
Intervention Type
Device
Intervention Name(s)
Norditropin NordiFlex®
Intervention Description
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
Primary Outcome Measure Information:
Title
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
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
Title
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
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
Secondary Outcome Measure Information:
Title
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
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
Title
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
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
Title
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
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
Title
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
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
Title
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
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
Title
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
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
Title
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
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
Title
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
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
Title
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
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
Title
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
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
Title
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
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
Title
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
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
Title
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
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
Title
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Paris La défense cedex
ZIP/Postal Code
92932
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23737664
Citation
Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex(R) French Study Group. User assessment of Norditropin NordiFlex((R)), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013. Erratum In: Patient Prefer Adherence. 2013 Aug 19;7:803.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
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