Growth Hormone DisorderNCT01327924
Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone
An observational study of 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 purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder
- What is being tested?
- Norditropin NordiFlex®
- Type of treatment
- Injection or infusion
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Growth hormone treatment naïve children for whom a prescription of Norditropin NordiFlex® is initiated according to the SPC (Summary of Product Characteristics)
Who may be able to join
- Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
- Subjects who receive Norditropin NordiFlex® according to the SPC
Who cannot join
- Known or suspected allergy to study product(s) or related products
- Child and/or parent unable to give consent or fill out the questionnaires
- The receipt of any investigational medicinal product within 3 months prior to this study
- Suffer from a life-threatening disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life
This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome, Foetal Growth Problem, Small for Gestational Age
- 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®Drug
Daily administration by 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 |
|---|---|---|
| Norditropin NordiFlex® users | Not described Receives: Drug: Norditropin NordiFlex® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of growth hormone injection device assessed by a quantitative scale
Measured: after 3 months of growth hormone treatment
Secondary outcomes (2)
Number of adverse events
Measured: from 0 - 3 months of growth hormone treatment
Number of technical complaints
Measured: from 0 to 3 months of growth hormone treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 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
- NCT01327924
- Sponsor's protocol ID
- GH-3870
- Other IDs
- U1111-1119-8619
- Status last verified
- Jun 2014
- First submitted
- 31 Mar 2011
- Last updated
- 24 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life
- ClinicalTrials.gov ID
- NCT01327924
- Acronym / sponsor ID
- GH-3870
- Conditions
- Growth Hormone Disorder, Growth Hormone Deficiency in Children, Genetic Disorder, Turner Syndrome, Foetal Growth Problem, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
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 purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Norditropin NordiFlex® users | – | Drug: Norditropin NordiFlex® |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Growth hormone treatment naïve children for whom a prescription of Norditropin NordiFlex® is initiated according to the SPC (Summary of Product Characteristics)
Key inclusion criteria (2 listed)
- Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
- Subjects who receive Norditropin NordiFlex® according to the SPC
Key exclusion criteria (4 listed)
- Known or suspected allergy to study product(s) or related products
- Child and/or parent unable to give consent or fill out the questionnaires
- The receipt of any investigational medicinal product within 3 months prior to this study
- Suffer from a life-threatening disease
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 subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice. | Drug | Norditropin NordiFlex® users |
Primary outcome
Usability of growth hormone injection device assessed by a quantitative scale
Time frame: after 3 months of growth hormone treatment
2 secondary outcomes
Number of adverse events
Time frame: from 0 - 3 months of growth hormone treatment
Number of technical complaints
Time frame: from 0 to 3 months of growth hormone treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- 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?
An observational study of 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 4 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 24 Jun 2014. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Usability of growth hormone injection device assessed by a quantitative scale (time frame: after 3 months of growth hormone treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2014.