Growth Hormone DisorderPhase 4NCT01245374
Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents
A Phase 4 study testing Norditropin NordiFlex® in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem
- What is being tested?
- Norditropin NordiFlex®
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Apr 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Children who can receive Norditropin® (somatropin) treatment according to the product labelling
- Treated with growth hormone for at least one year
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents
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.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age, Genetic Disorder, Turner Syndrome
- Being tested
- Norditropin NordiFlex®
- Medical subject headings
- Genetic Diseases, Inborn, Turner Syndrome, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norditropin NordiFlex®Device
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
| Study group | Role | What they receive |
|---|---|---|
| Nordiflex Norditropin® | Experimental | 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) Receives: Device: Norditropin NordiFlex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6
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.
Measured: Week 6
Secondary outcomes (15)
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).
Measured: Week 0
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).
Measured: Week 0
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).
Measured: Week 0
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.
Measured: Week 0
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).
Measured: Week 6
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).
Measured: Week 6
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).
Measured: Week 6
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.
Measured: Week 6
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).
Measured: Week 6
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.
Measured: Week 6
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.
Measured: Week 6
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.
Measured: Week 0
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.
Measured: Week 6
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.
Measured: Week 6
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial
Measured: Weeks 0 - 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245374
- Sponsor's protocol ID
- GH-3826
- Other IDs
- U1111-1117-1194, 2009-017387-16, 2009
- Status last verified
- Jan 2017
- First submitted
- 19 Nov 2010
- Last updated
- 27 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23737664
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents
- ClinicalTrials.gov ID
- NCT01245374
- Acronym / sponsor ID
- GH-3826
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Foetal Growth Problem, Small for Gestational Age, Genetic Disorder, Turner Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 22 Nov 2010 (estimated)
- Results
- Posted 25 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nordiflex Norditropin® | Experimental | Device: 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) |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Children who can receive Norditropin® (somatropin) treatment according to the product labelling
- Treated with growth hormone for at least one year
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norditropin 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 | Device | Nordiflex Norditropin® |
Primary outcome
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Time frame: 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.
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used
Time frame: Week 6
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.
15 secondary outcomes
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Time frame: Week 0
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Dose Modification
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness
Time frame: Week 6
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Time Learning
Time frame: Week 6
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products
Time frame: Week 6
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Time frame: Week 0
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection
Time frame: Week 6
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment
Time frame: Week 6
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23737664Tauber 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Norditropin NordiFlex® in people with Growth Hormone Disorder and Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01245374, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.