Growth Hormone DeficiencyNCT00738205
Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector
An observational study of Growth Hormone Deficiency and Turner Syndrome, run by Merck KGaA, Darmstadt, Germany.
Trial summary
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure
- How many people
- 834 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Jun 2009
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Overall, 834 children using the electronic auto-injector were recruited. Of these, 824 children were included in the evaluable population. Of the 824 evaluable children, 601 were treatment-naïve and 223 were treatment-experienced.
Who may be able to join
- Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP)
Who cannot join
- Cases in which Saizen® is contra-indicated (based on local RCP)
- Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
- Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study
About this study
Official title: Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders
This is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.
Read the detailed description
An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.
The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Keywords
- Electronic device, Growth hormone treatment
- Medical subject headings
- Dwarfism, Pituitary, Turner Syndrome, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children.
Measured: week 12
Secondary outcomes (1)
To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJun 2007
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- 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
- 834 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clément Olivier, MD, LMCC, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738205
- Sponsor's protocol ID
- Easypod
- Status last verified
- Mar 2014
- First submitted
- 19 Aug 2008
- Last updated
- 11 Mar 2014
- Results posted
- No
Publications
Bozzola M, Colle M, Halldin-Stenlid M, Larroque S, Zignani M; easypod survey study group. Treatment adherence with the easypod growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents. BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.
PubMed 21294891
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Convenience and Compliance of the Easypod™ Electronic Self-injector When Administering Saizen® Growth Hormone to Children With Growth Disorders
- ClinicalTrials.gov ID
- NCT00738205
- Acronym / sponsor ID
- Easypod
- Conditions
- Growth Hormone Deficiency, Turner Syndrome, Chronic Renal Failure, Small for Gestational Age
- Keywords
- Electronic device, Growth hormone treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 834 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 20 Aug 2008 (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 is an international, multicenter study involving children treated with Saizen®, a growth hormone, who will be trained to use easypod, a new electronic injector and will complete a questionnaire after 12 week of use.
Both children naïve to growth hormone and dissatisfied with their current injection device will be recruited.
Detailed description
An international, multicenter cross-sectional study (Observatoire des pratiques médicales®) involving a cohort of children treated with Saizen®, a growth hormone.
The study does not require any changes to the usual medical management of these patients and should not be considered detrimental to their physical or psychological integrity. No specific procedures or examinations will be requested, nor does the protocol require any particular treatment or follow-up visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Overall, 834 children using the electronic auto-injector were recruited. Of these, 824 children were included in the evaluable population. Of the 824 evaluable children, 601 were treatment-naïve and 223 were treatment-experienced.
Key inclusion criteria (1 listed)
- Already treated patients who are dissatisfied with their current self-injection device, or naïve pediatric patients, in cases for which this indication is validated (growth hormone deficiency, Turner's syndrome, chronic renal failure, small-for-gestational age [SGA] patients, based on RCP)
Key exclusion criteria (3 listed)
- Cases in which Saizen® is contra-indicated (based on local RCP)
- Children returning for consultation, who have not brought back their Easypod™ electronic self-injector.
- Children who are participating in a therapeutic trial, or who have done so in the 3-month period preceding their recruitment into this observational study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children.
Time frame: week 12
1 secondary outcome
To assess the acceptability of the new Easypod™ electronic injector for children following a growth hormone treatment regimen.
Time frame: week 12
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 11 Mar 2014.
- Results publication: PubMed 21294891Bozzola M, Colle M, Halldin-Stenlid M, Larroque S, Zignani M; easypod survey study group. Treatment adherence with the easypod growth hormone electronic auto-injector and patient acceptance: survey results from 824 children and their parents. BMC Endocr Disord. 2011 Feb 4;11:4. doi: 10.1186/1472-6823-11-4.
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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.
Clément Olivier, MD, LMCC study director
Merck Serono S.A., Geneva
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency and Turner Syndrome, run by Merck KGaA, Darmstadt, Germany.
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 1 inclusion and 3 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 11 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
To assess children's compliance with the Saizen®, growth hormone treatment, following introduction of the new easypodTM self-injector, while comparing newly treated and previously treated children. (time frame: week 12). 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 NCT00738205, 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 11 Mar 2014.