Growth DisordersPhase 3NCT00450190
Saizen® E-Device User Trial
A Phase 3 study testing Saizen® E-Device in people with Growth Disorders, run by Merck KGaA, Darmstadt, Germany.
Trial summary
The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Growth Disorders
- What is being tested?
- Saizen® E-Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2006to 30 Sep 2006
- Phase
- Phase 3
- 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 Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC)
- Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent
Who cannot join
- Known hypersensitivity to somatropin or any of the excipients
- Epiphyseal fusion
- Active neoplasia (either newly diagnosed or recurrent)
- History of intracranial hypertension with papilledema
- Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL
- Severe congenital malformations
Show all 19Show fewer
- Severe psychomotor retardation
- Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
- Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
- Chronic infectious disease
- Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
- Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
- Proliferative or preproliferative diabetic retinopathy
- Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
- Precocious puberty
- Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
- Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
- Participation to any clinical study within the 30 days preceding study entry
- Pregnancy
About this study
Official title: User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.
- Conditions
- Growth Disorders
- Being tested
- Saizen® E-Device
- Keywords
- Growth disorders
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saizen® E-DeviceDevice
Saizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Saizen® E-Device | Experimental | Not described Receives: Device: Saizen® E-Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects' Overall Impression After Using E-Device
Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
Measured: 2 Weeks
Usefulness and Reliability of E-Device Functions
Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.
Measured: 2 Weeks
Secondary outcomes (3)
Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Subjects' feedback immediately after initial training on the handling and use of E-Device was assessed on scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Subjects were provided training on the following aspects: Cartridge loading, Needle attachment, Needle detachment, Injection process, Navigation in the menu, and Handling of the device. Number of subjects with response based on their feedback were presented.
Measured: Inclusion visit (Day 1)
Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Nurse/physician's feedback was assessed for E-Device setting up and Dose programming on inclusion visit using a scale ranging from 1 to 3, where 1 = difficult, 2 = easy, and 3 = very easy. Nurse/Physician's response for the number of subjects were presented.
Measured: Inclusion visit (Day 1)
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
An Adverse Event (AE) was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect, AEs leading to discontinuation and AEs leading to death.
Measured: Day 1 up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2007 (estimated)
- Study start28 Feb 2006
- Primary completion30 Sep 2006
- Study completion30 Sep 2006
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 DisordersStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00450190
- Sponsor's protocol ID
- 26443
- Status last verified
- Sep 2017
- First submitted
- 21 Mar 2007
- Last updated
- 23 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Tauber M, Payen C, Cartault A, Jouret B, Edouard T, Roger D. User trial of Easypod, an electronic autoinjector for growth hormone. Ann Endocrinol (Paris). 2008 Dec;69(6):511-6. doi: 10.1016/j.ando.2008.04.003. Epub 2008 Jun 26.
PubMed 18589398
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
- ClinicalTrials.gov ID
- NCT00450190
- Acronym / sponsor ID
- 26443
- Conditions
- Growth Disorders
- Keywords
- Growth disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2006 (actual)
- Primary completion
- 30 Sep 2006 (actual)
- Study completion
- 30 Sep 2006 (actual)
- First posted
- 22 Mar 2007 (estimated)
- Results
- Posted 23 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saizen® E-Device | Experimental | Device: Saizen® E-Device |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age [SGA] according to the local SmPC)
- Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent
Key exclusion criteria (19 listed)
- Known hypersensitivity to somatropin or any of the excipients
- Epiphyseal fusion
- Active neoplasia (either newly diagnosed or recurrent)
- History of intracranial hypertension with papilledema
- Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose > 116 mg/dL
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 |
|---|---|---|
| Saizen® E-DeviceSaizen® (recombinant human growth hormone [r-hGH]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days. | Device | Saizen® E-Device |
Primary outcome
Subjects' Overall Impression After Using E-Device
Time frame: 2 Weeks
Subjects' overall impression after using E-Device was measured on a scale ranging from 1 to 3, where 1 = bad, 2 = good, and 3 = very good. Number of subjects with response based on overall impression scale were presented.
Usefulness and Reliability of E-Device Functions
Time frame: 2 Weeks
Following functions were assessed: Display of remaining dose in cartridge, Display of last injection date and time, Automatic needle attachment, Audible and visual signals, Dose injected confirmation, Dose history, Customizable needle insertion speed, Customizable drug insertion speed, Customizable insertion depth, Teach me menu, On screen instructions, Customizable name and picture, Pre-programmed dose and Skin sensor. Usefulness and reliability of each of the E-Device functions was measured on a scale ranging from 1 to 3, where 1 = not useful, 2 = useful, and 3 = very useful. Number of subjects with response based on usefulness and reliability scale were presented.
3 secondary outcomes
Subjects' Feedback Immediately After Initial Training During Inclusion Visit
Time frame: Inclusion visit (Day 1)
Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit
Time frame: Inclusion visit (Day 1)
Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18589398Tauber M, Payen C, Cartault A, Jouret B, Edouard T, Roger D. User trial of Easypod, an electronic autoinjector for growth hormone. Ann Endocrinol (Paris). 2008 Dec;69(6):511-6. doi: 10.1016/j.ando.2008.04.003. Epub 2008 Jun 26.
- Full FDA approved prescribing information can be found hereLink 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.
Medical Responsible study director
Merck Lipha Santé s.a.s., an affiliate of Merck KGaA, Darmstadt, Germany
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saizen® E-Device in people with Growth Disorders, 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 2 inclusion and 19 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 23 Jul 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 23 Jul 2018). 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?
Subjects' Overall Impression After Using E-Device (time frame: 2 Weeks). 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 NCT00450190, 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 23 Jul 2018.